Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Background: Small cell lung cancer (SCLC) is the deadliest form of lung cancer. Extrapulmonary neuroendocrine cancer (EPNEC) is a similar type of cancer that develops anywhere other than the lungs. EPNEC is also deadly. B7-H3 is a protein often found in SCLC and EPNEC tumor cells. Researchers can modify a person s own T cells, or immune cells, to target B7-H3. When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells. Objective: To test B7-H3 CAR T cell therapy in people with SCLC or EPNEC. Eligibility: People aged 18 years and older with SCLC or EPNEC that either did not respond or returned after treatment. Design: Participants will be screened. They will have blood tests and tests of their heart function. They will have imaging scans. Participants will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be altered to make them attack cells with B7-H3. Participants will be in the hospital for at least 15 days. They will receive chemotherapy drugs to prepare their body for the treatment. These drugs will be given through a tube attached to a needle inserted into a vein. The modified T cells will be infused through a vein. Participants will remain in the hospital until they are well enough to go home. Follow-up visits will continue for 15 years....
Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
This is a multicenter, open-label, Phase 1/2 master protocol evaluating autologous dual-target CAR-T cell therapy in adults with advanced solid cancers. After central biomarker screening, each participant is assigned the best-matched dual-target construct from a predefined target-pair library. The trial is designed to test whether biomarkerguided dual targeting can improve tumor control, reduce antigenescape risk, and preserve safety in solid tumors.
GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours
Only enrolling in Canada. The purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers
GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)
This study is being conducted in patients with GPC3-positive brain tumors that have recurred or have not responded to standard therapy. Atypical teratoid rhabdoid tumors (ATRT) are aggressive tumors with poor outcomes and limited treatment options, particularly in young children. There is a need for new therapies that can improve outcomes while minimizing toxicity. This study evaluates a new experimental treatment using genetically engineered T cells (RADIANT-T cells) that target glypican-3 (GPC3), a protein expressed on tumor cells. These T cells are modified to express a chimeric antigen receptor (CAR) targeting GPC3, along with IL-15 and IL-21 to enhance their persistence and activity. The cells also include an inducible safety mechanism (iCasp9) that allows them to be eliminated if necessary. The purpose of this study is to determine the highest safe dose of RADIANT-T cells, evaluate their safety and side effects, assess how long they persist in the body, and determine whether they show anti-tumor activity in patients with GPC3-positive brain tumors.
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
This is a phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without paclitaxel and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 in combination with trastuzumab or cetuximab; each objective will be assessed with or without paclitaxel chemotherapy.
GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies
Background: A new cancer treatment takes a person s own T cells, modifies them in a laboratory so they can better fight cancer cells, and then gives them back to the person. Researchers want to see if this treatment can help people with a certain types of cancer. Objective: To see if a personalized immune treatment, anti-GPC3 CAR-T cells, is safe. Eligibility: Adults aged 18 years and older who have Glypican-3 (GPC3) positive solid tumor malignancy. Design: Participants will be screened with the following: Blood and urine tests Medical history Physical exam Heart function tests Review of their symptoms and their ability to perform their normal activities Tumor biopsy Imaging scan of the chest, abdomen, and pelvis Participants will have leukapheresis. They may have an IV (intravenous catheter, a small tube put into an arm vein) inserted into each arm or get a central line. Blood will be removed. A machine will separate the white blood cells from their blood. The rest of their blood will be returned to them. Participants will be admitted to the hospital for about 2 weeks. They will get the chemotherapy drugs fludarabine and cyclophosphamide by IV for 3 days. Then they will receive the modified white blood cells by IV. Participants will have frequent blood draws. They will give blood and tumor samples for research. Participants will have follow-up visits for the next 15 years. Then they will be contacted by email or phone for the rest of their life. If their disease does not get worse after 5 years, they will continue to be invited to do imaging studies every 6 months.
Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CARE T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that they can put a new gene (a tiny part of what makes-up DNA and carries a person's traits) into T cells that will make them recognize cancer cells and kill them. In the lab, investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR more effective, investigators also added two genes that includes IL15 and IL21, which are protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 plus IL21 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15 plus IL21 .This study will test T cells that investigators made (called genetic engineering) with GPC3-CAR and the IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The investigators will insert the iCasp9 and IL15 plus IL21 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects. This study will test T cells genetically engineered with a GPC3-CAR and IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors. The CARE T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of CARE T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the CARE T cells will help people with GPC3-positive solid tumors.
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Background: In a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70. Objectives: To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe. Eligibility: Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer. Design: Participants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Eligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital. Participants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis. Participants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam. Throughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.
Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer
Background: Many cancer cells produce substances called antigens that are unique to each cancer. These antigens stimulate the body s immune responses. One approach to treating these cancers is to take disease-fighting white blood cells from a person, change those cells so they will target the specific proteins (called antigens) from the cancer cells, and return them to that person s blood. The use of the white blood cells in this manner is one form of gene therapy. A vaccine may help these modified white cells work better. Objective: To test a cancer treatment that uses a person s own modified white blood cells along with a vaccine that targets a specific protein. Eligibility: Adults aged 18 to 72 years with certain solid tumors that have spread after treatment. Design: Participants will undergo leukapheresis: Blood is removed from the body through a tube attached to a needle inserted into a vein. The blood passes through a machine that separates out the white blood cells. The remaining blood is returned to the body through a second needle. Participants will stay in the hospital for 3 or 4 weeks. They will take chemotherapy drugs for 1 week to prepare for the treatment. Then their modified white cells will be infused through a needle in the arm. They will take other drugs to prevent infections after the infusion. The vaccine is injected into a muscle; participants will receive their first dose of the vaccine on the same day as their cell infusion. Participants will have follow-up visits 4, 8, and 12 weeks after the cell infusions. They will receive 2 or 3 additional doses of the boost vaccine during these visits. Follow-up will continue for 5 years, but participants will need to stay in touch with the gene therapy team for 15 years. ...
3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN
Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study agent is called IL13Ralpha2 CAR T cells. T cells are a special type of white blood cell (immune cells) that have the ability to kill tumor cells. The T cells are obtained from the patient's own blood, grown in a laboratory, and modified by adding the IL13Ralpha2 CAR gene. The IL13Ralpha2 CAR gene is inserted into T cells with a virus called a lentivirus. The lentivirus allows cells to make the IL13Ralpha2 CAR protein. This CAR has been designed to bind to a protein on the surface of tumor cells called IL13Ralpha2. This study is being done to determine the dose at which the gene-modified immune cells are safe, how long the cells stay in the body, and if the cells are able to attack the cancer.
FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma
Background: Rhabdomyosarcoma (RMS) is a cancer of soft tissues. It is the most common soft tissue sarcoma seen in children. RMS cancer cells have a protein called FGFR4 on their surface. Researchers want to try a new kind of treatment for RMS: They will collect a person s own T cells, a type of immune cell; then they will change the T cells so they are better able to target the FGFR4 protein and attack RMS tumor cells. The modified T cells are chimeric antigen receptor (CAR) T cells. The treatment in this study is called FGFR4-CAR T cells. Objective: To test FGFR4-CAR T cells in children and young adults with RMS. Eligibility: People aged 3 to 39 years with RMS. The RMS must have failed to respond or returned after at least 2 rounds of standard treatment. Design: Participants will be screened. They will have physical exam, imaging scans, blood tests, and tests of their heart. They may have a tissue sample taken from their tumor. They will undergo apheresis: Blood will be taken from the body through a catheter. The blood will pass through a machine that separates out the T cells, and the remaining blood will be returned to the body. The collected T cells will be taken to a lab to create FGFR4-CAR T cells. Once the FGFR4-CART cells are ready, participants can receive these T cells. For 4 days they will receive drugs to prepare their body for the FGFR4-CAR T cells. After this, the modified T cells will be infused into a vein. Participants will be then monitored closely to watch for any side effects from the CART cells and be followed to see what effect the CART cells have on their tumors. They will have follow-up visits for up to 5 years. Long-term follow-up will be another 10 years.
Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Targeted Activated DC combined with CAR-T therapy in patients with Advanced Solid Cancers.This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors
Protocol GVO-1102 is a phase 1, open label, multi-center study in adult patients with locally advanced or metastatic solid tumors. This study includes two parts: dose escalation and dose expansion. In the dose escalation phase, GEN2 will be administered at increasing dose levels via intravenous infusion or intratumoral injection on Days 1, 3 and 8 every 4 weeks. Valganciclovir will start dosing on Day 12 and continue for 10 days (through Day 21). Once a recommended dose has been defined in approximately 35-45 patients, the dose expansion phase will initiate to further assess intravenous administration of GEN2 in specific tumor types. Approximately 15 patients per tumor type will be enrolled in the intravenous dose expansion phase.
Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells for Solid Tumors
Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CATCH T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carriesa person's traits) into T cells that will make them recognize cancer cells and kill them . In the lab, we made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33. The antibody GC33 recognizes a protein called GPC3 that is found on the hepatocellular carcinoma the patient has. The specific CAR we are making is called GPC3-CAR. To make this CAR more effective, we also added a gene encoding protein called IL15. This protein helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL 15. This study will test T cells that we have made with CATCH T cells in patients with GPC3-positive solid tumors such as the ones participating in this study. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The investigators will insert the iCasp9 and IL15 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects. This study will test T cells genetically engineered with a GPC3-CAR and IL15 (CATCH T cells) in patients with GPC3-positive solid tumors. The CATCH T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of CATCH T cells that is safe , to see how long they last in the body, to learn what the side effects are and to see if the CATCH T cells will help people with GPC3-positive solid tumors.
CD70.CAR for CD70+ Lymphoma, Myeloma and Solid Tumors
This study is for patients who have a type of cancer that expresses the protein CD70, which includes lymphoma (lymph gland cancer), myeloma and solid tumors including some sarcomas and kidney cancers, and the cancer has come back or has not gone away after standard of care treatment. As there are limited or no remaining standard treatments available to treat this cancer, patients are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the tumor cells in the body. This research study combines different ways of fighting disease by using T cells and "arming" them to recognize a specific protein on cancer cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T cells by themselves have been used to treat patients with cancers and have shown promise, but have not been strong enough to cure most patients. The protein used in this study is called anti-CD70. It has been developed from human CD27 on normal T cells, since it is the natural binding partner that can connect with CD70. This anti-CD70 protein sticks to tumor cells when it binds to CD70. CD70 binders have been used to treat people with different types of cancers. For this study, anti-CD70 has been changed so that instead of floating free in the blood it is now joined to the T cells. When binder is joined to a T cell in this way it is called a chimeric receptor or "CAR T cell". The doctors then made another change to cause these T cells to kill any cell that has CD70. This causes the "CAR T cells" to kill blood cancer cells which are confirmed to have CD70. In the laboratory, investigators have found that T cells work better if there are proteins added that stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on tumor cells but also stimulates the T cells that express it. Adding the CD27 makes the cells grow better and may help them to last longer in the body, thus giving the cells a better chance of killing the tumor cells. These CD70 "CAR" T cells are investigational products not approved by the Food and Drug Administration. The purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy might help people with lymphoma (lymph gland cancer), myeloma and certain solid tumors including some sarcomas and kidney cancers.
Safety and Efficacy of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors
A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after complete standard treatments.
Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours
This is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP3 in adult participants with advanced solid tumors, to evaluate the safety and tolerability of RP3 both as a single agent and in combination with anti-PD1 therapy and to determine the recommended Phase 2 dose (RP2D) of RP3.
Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies
The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body). This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.
A Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors
The proposed clinical study is a Phase 1/2a trial to investigate the safety, tolerability, pharmacokinetics and clinical activity of anti-HLA-G CAR-T cells IVS-3001 administered to subjects with previously treated, locally advanced, or metastatic solid tumors which are HLA-G positive (HLA-G+) - as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody.
Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose that is safe for patients Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: Enrollment and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen Tmod CAR T cells at the assigned dose
An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.
An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.
EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide/fludarabine (CY/FLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced/metastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells). A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Background: Mesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN. Objective: To test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma. Eligibility: People aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment. Design: Participants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN. Participants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. Participant s T cells will be modified in a lab to produce TNhYP218 CAR T cells. Participants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment. TNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days. After discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy. Long-term follow-up will continue another 10 years.
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
This is a Phase I, FIH, open-label, multi-site, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6 ribonucleic acid lipoplexes (RNA-LPX) in patients with CLDN6-positive relapsed or refractory advanced solid tumors.
Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
1. Study Title: Efficacy and safety of MSLN CAR-T in advanced malignant tumors 2. Study Objectives: Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III/IV advanced malignant tumors. Secondary: To preliminarily evaluate the efficacy of MSLN-targeted CAR-T cell therapy in this patient population. Exploratory: To assess in vivo expansion and persistence of infused MSLN-targeted CAR-T cells and explore correlations with clinical outcomes. 3. Participant Intervention: Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
A Clinical Gene Therapy Study With Hematopoietic Stem Cells for the Treatment, With Single Dose of Temferon, of Patients Suffering From Metastatic Renal Cell Carcinoma
This is an open label, single-centre phase 1/2 study involving a single dose of Temferon, an investigational Advanced Therapy Medicinal Product (ATMP), to treat patients with metastatic clear cell renal cell carcinoma (RCC) with evidence of disease progression following at least two lines of standard of care (SoC) treatments.
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below.
A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT
This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment.
Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies
The purpose of the study is to find out if an investigational drug called PRGN-3007 UltraCAR-T cells (PRGN-3007 T cells) can help people with ROR1-positive hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid tumor triple negative breast cancer (TNBC) malignancies.
Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors
This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer. This study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cells called HER2 chimeric antigen receptor specific cytotoxic T lymphocytes (HER2 specific CAR T cells), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus that is designed to help the immune system including HER2 specific CAR T cell react to the tumor. The study is looking at combining these two treatments together, because we think that the combination of treatments will work better than each treatment alone. We also hope to learn the best dose level of the treatments and whether or not it is safe to use them together. In this study, CAdVEC will be injected into participants tumor at one tumor site which is most easiest to reach. Once it infects the cancer cells, activation of the immune response will occur so it can attack and kill cancer cells. (This approach may have limited effects on the other tumor sites that have not received the oncolytic virus injection, so, patients will also receive specific T cells following the intratumor CAdVEC injection.) These T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. Investigators want to see if these cells can survive in the blood and affect the tumor. Both CAdVEC and HER2-specific autologous CAR T are investigational products. They are not approved by the FDA.
Engineered T-Cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of ALPP CAR-T cells in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.
Engineered T-cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of ALPP CAR-T cells in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
B7-H3.CD28Z.CART in Solid Tumors
The goal of this research study is to test if a new cell therapy (B7-H3.CD28Z.CART / B7-H3 CAR T cells) is safe and effective in treating children and young adults with solid cancers whose tumors have returned or stopped responding to standard treatments (relapsed or refractory) and have been identified with a B7-H3 marker. The names of the treatment interventions used in this study are: * B7-H3.CD28Z.CART / B7-H3 CAR T cells * Fludarabine * Cyclophosphamide
Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called AGAR T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that they can put a new gene (a tiny part of what makes-up DNA and carries your traits) into T cells that will make them recognize cancer cells and kill them. In the lab, investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR more effective, investigators also added a gene that includes IL15. IL15 is a protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15 .This study will test T cells that investigators made (called genetic engineering) with GPC3-CAR and the IL15 (AGAR T cells) in patients with GPC3-positive solid tumors such as yours. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called Rimiducid. The investigators will insert the iCasp9 and IL15 together into the T cells using a virus that has been made for this study. The drug (Rimiducid) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects. This study will test T cells genetically engineered with a GPC3-CAR and IL15 (AGAR T cells) in patients with GPC3-positive solid tumors. The AGAR T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of AGAR T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the AGAR T cells will help people with GPC3-positive solid tumors.
TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-G203 in patients with GPC3-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
HV-101 for Patients With Advanced Solid Tumors
Background: Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to treat patients. TIL therapy has shown strong efficacy for the treatment of solid tumors, and has achieved high objective response rates in multiple cancers. Objective: To evaluate the safety and efficacy of HV-101 for the treatment of advanced solid tumors. Eligibility: Adults aging 18-75 with advanced solid tumors Design: 1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests. 2. Freshly resected patient tumors were dissected by the surgeon. 3. TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded. 4. HV-101 will be re-infused into the patient.
ALPP CAR-T Cells for ALPP-Positive Advanced Solid Tumors
Alkaline phosphatase (ALP) is a membrane-bound glycoprotein that catalyzes the hydrolysis of phosphates at alkaline pH values. As one of the earliest discovered oncofetal antigens, ALP has emerged as a significant biomarker for various malignant tumors, such as ovarian cancer, breast cancer, trophoblastic tumors, germ cell tumors, endometrial cancer, testicular tumors, cervical intraepithelial neoplasia, and gastrointestinal tumors.
Anti-ALPP CAR-T Cells Immunotherapy for Advanced Solid Tumors
The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive Advanced Solid Tumors.
Follow-Up Evaluation for Gene-Therapy-Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials
Background: \- Gene therapy involves changing the genes inside the body s cells to stop disease. It is very closely regulated. People who have had this therapy may have problems months or even years later. Researchers do not know the long-term side effects, so they want to study people who have had the therapy. They want the study to continue over the next 15 years. Objective: \- To study over time the negative side effects from genetically engineered cellular therapy. This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy trials. Eligibility: \- People who are currently or were previously in a research study with gene therapy in the National Cancer Institute POB. Design: * Participants blood will be tested right before they get the genetically changed cells. They will get the cells as part of another study. * For the next year, they will come back to the clinic or see their doctor at home at least every 3 months. They will answer questions about their health and blood will be drawn. * For the next 5 years, they will go to the clinic or see their own doctor once a year. They will have physical exam and blood will be drawn. * For 10 years after that, they will be asked every year for health information. * Participants will keep their contact information up to date with researchers. They may be phoned for more health information. * If the participant was under 18 years old when given the gene therapy and turns 18 during this follow-up, they will be asked to sign a new consent form when they turn 18.
A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Eligible participants for this LTFU study include patients who received at least 1 dose of an RPx product under the interventional parent study. Patients will be rolled over into this LTFU study after completion of the Replimune-sponsored parent study (ie, either completion of the LTFU in the parent study or withdrawal from the parent study). All patients in ongoing RPx studies will be asked to participate in this LTFU study so that the Sponsor can evaluate potential delayed risks.
Immune Reconstitution Monitoring and Pneumococcal Vaccination in Patients Treated With CAR-T Cells
This is a prospective interventional study designed to investigate the effect of Immune Reconstitution clinic visits and pneumococcal vaccination (PCV-21) on infection risk, anti-infective prophylaxis adherence, and vaccine response in patients receiving CAR-T therapy following lymphodepletion. Fifty subjects (20 receiving commercial CAR-T for CD19 or BCMA and 30 receiving investigational CAR-T) will be enrolled. Subjects will attend Immune Reconstitution Clinic Visits at 3, 6, 9, and 12 months after CAR-T cell infusion. Subjects will be asked to provide blood samples at pre-defined intervals during CAR-T visits which will be assessed for immune composition, vaccine titers, viral titers, and immunoglobulins. Samples will be primarily used for study purposes. Leftover blood will be stored for up to five years after the last study visit and may be used for future research. Vaccination against pneumococcal pneumonia will be offered at 6 months post-CAR-T infusion at the Immune Reconstitution Clinic Visit. Subjects will provide additional blood samples at 9- and 12 months post CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies to determine vaccine efficacy. Long-term follow-up will continue for up to 24 months post-CAR-T infusion via medical chart abstraction. This pilot study investigates immune reconstitution, infection risk, and vaccine response in patients receiving chimeric antigen receptor (CAR)-T cell therapy following lymphodepletion. Subjects will undergo lymphodepletion followed by CAR-T cell infusion will be included. The only additional treatment for subjects in this study is the PCV-21 pneumococcal vaccine. All CAR-T treatment procedures will adhere to the standard-of-care or the clinical trial protocol to which the subject is co-enrolled. Subjects will provide blood samples at predefined intervals during CAR-T visits. These samples will be assessed for various laboratory studies, including blood counts, immune cell composition, viral titers, immunoglobulins, and microbiome composition. Vaccination against pneumococcal pneumonia will be given 6 months post-CAR-T- T infusion. Subjects who opt for this vaccination will provide additional blood and blood samples at collected at 6, 9, and 12 months post-CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies. Long-term follow-up will continue for up to 24 months post-CAR-T infusion through medical chart abstraction
Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2)
The goal of this Phase I/II observational and interventional platform study is to evaluate the safety and efficacy of multiple types of innovative anti-tumor drugs and new technologies in patients with rare solid tumors. The study utilizes multi-dimensional precision screening (including WES, RNAseq, mIHC, and quantitative proteomics) to match patients with specific sub-protocols. Key questions it aims to answer: Assess the safety of innovative therapies in rare tumor populations. Evaluate the objective response rate (ORR) and other efficacy metrics. Explore biomarkers related to therapeutic efficacy. Participants: Patients with metastatic or advanced rare solid tumors who have failed standard therapy or have no standard treatment options.
Immune Profiling for Cancer Immunotherapy Response
In patients clinically treated with FDA-approved immunotherapy the investigators will assess the predictive value of pre- and on-treatment 1) immune-methylation profiling across cancer types, and 2) immune-methylation profiling and cytokine profiling within cancer types.
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.
CAR-T for Claudin18.2 Positive Solid Tumors
The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product. The main questions it aims to answer are: 1. What CAR-T-related adverse events (AEs) occur within 3 months after the autologous CAR-T cell infusion? 2. What is the Objective Response Rate (ORR), Progression-free survival (PFS), duration of response (DOR), and overall survival (OS)? Participants will: 1. Undergo leukapheresis for collection of autologous T cells for CAR-T cell manufacturing. 2. May receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) for 3 consecutive days if clinically needed. 3. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. 4. Receive autologous CAR-T cells infusion on Day 0. 5. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 6. Visit the clinic at Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers
Background: Researchers have found a new way to treat cancer using T cell therapy. The therapy used in this study is T Cell Receptor (TCR) Gene Therapy Targeting Kita-Kyushu Lung Cancer Antigen-1 (KK-LC-1), a cancer germline antigen that is expressed by certain cancers. This therapy is a type of treatment in which participants T cells (a type of immune system white blood cell) are changed in the laboratory to attack cancer cells and given back to the participant. This treatment might help people with KK-LC-1 positive cancers which may include gastric, breast, cervical, lung and other epithelial Cancers. Epithelial cancers are cancers that begin in the cells that line an organ. Objective: The purpose of this study is to determine the safety of different doses of KK-LC-1 TCR T cells plus aldesleukin to treat metastatic or refractory/recurrent KK-LC-1 positive cancers. Eligibility: Adults aged 18 and older with metastatic or refractory/recurrent KK-LC-1 positive epithelial cancer. Design: Participants will be screened with human leukocyte antigen (HL)typing (a blood test needed for eligibility) and KK-LC-1 testing of the cancer tumor (to determine if the cancer is KK-LC-1 positive). A new biopsy may be needed if tumor from an outside location is not available for KK-LC-1 testing. Eligible participants will come to the National Institutes of Health (NIH) campus to have a screening evaluation which will include physical exam, review of medical history and current medications, blood and heart tests, imaging (X-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI) or positron emission tomography (PET) scan), and evaluation of participants veins that are used for drawing blood. If the participant is eligible for the study based on the screening evaluation, they will have a baseline evaluation prior to receiving the experimental treatment which may include additional laboratory or imaging tests. Participants will have a large intravenous (IV) catheter inserted into a vein to undergo a procedure called leukapheresis. Leukapheresis is the removal of the blood by a machine to collect specific white blood cells. The remaining blood is returned to the body. This procedure is needed to collect the cells that will be modified to target the cancer. The cells are grown in the lab and given back to the participant through an injection into the participant's tumor. It takes 11-15 days to grow the cells. While the cells are growing, the participant will be admitted to the hospital about one week before the cell infusion to receive 2 types of chemotherapy through an IV catheter over 5 days. The main purpose of the chemotherapy is to make the cells more effective in fighting the cancer tumors. The cells will be given 1-2 days after the last dose of chemotherapy. Within 24 hours after the cell infusion, participants will be given a cell growth factor called aldesleukin through an IV for up to 4 days. Aldesleukin is thought to help the cells live longer in the participant's body. Participants will recover in the hospital until they are well enough to go home, which is usually about 7-12 days after the cell infusion or last dose of aldesleukin. Participants will have a follow-up visit at approximately 40 days after the date of cell infusion. This visit will be to evaluate the safety of the cell therapy and the response of the cancer to the treatment which will include physical examination, lab tests, and imaging studies. If a participant has stable disease or their cancer has responded to the treatment, they will be seen again at 12 weeks post cell infusion, every 3 months x 3 visits, and then every 6 months x 5 years. If a participants cancer progresses after this therapy, they will be return to their home doctor for further management. After receiving cell therapy, participants will be followed on a long-term gene therapy protocol. Participants will have blood drawn periodically to test if the cells have grown or changed. These blood tests will take place immediately before the cells, and then at 3, 6, and 12 months for the first year and possibly annually thereafter based on the results. These tests can be drawn locally and sent to the NIH. After a participant is off the study, they will be contacted by telephone or mailed questionnaire for a total of 15 years after cell therapy....
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a B7H3-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express B7H3. On Arm A of the study, research participants will receive B7H3-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at B7H3 and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. Arm A CAR T cells include the protein EGFRt and Arm B CAR T cells include the protein HER2tG. These proteins can be used to both track and destroy the CAR T cells in case of undue toxicity. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the participant's body on each arm. Participants will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each arm. Participants who experience significant and potentially life-threatening toxicities (other than clinically manageable toxicities related to T cells working, called cytokine release syndrome) will receive infusions of cetuximab (an antibody commercially available that targets EGFRt) or trastuzumab (an antibody commercially available that targets HER2tG) to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products.
EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a EGFR-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express EGFR and the selection-suicide marker EGFRt. EGFRt is a protein incorporated into the cell with our EGFR receptor which is used to identify the modified T cells and can be used as a tag that allows for elimination of the modified T cells if needed. On Arm A of the study, research participants will receive EGFR-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at EGFR and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. The CD19 receptor harbors a different selection-suicide marker, HERtG. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the subject's body on each arm. Subjects will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each arm. Subjects who experience significant and potentially life-threatening toxicities (other than clinically manageable toxicities related to T cells working, called cytokine release syndrome) will receive infusions of cetuximab (an antibody commercially available that targets EGFRt) or trastuzumab (an antibody commercially available that targets HER2tG) to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products.
Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors
This is a single-arm, open-label, Phase I study to evaluate the safety, tolerability, and antitumor activity of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103 CAR-T cell therapy.
Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors
A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors
Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors
This Phase 1, open-label, non-randomized study will enroll adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells). An adult participant meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.
Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. In order to get them to kill cancers more effectively, in the laboratory, the study team inserted a new gene called a chimeric antigen receptor (CAR) into T cells that makes them recognize cancer cells and kill them. When inserted, this new CAR T cell can specifically recognize a protein found on solid tumors, called glypican-3 (GPC3). To make this GPC3-CAR more effective, the study team also added two genes called IL15 and IL21 that help CAR T cells grow better and stay in the blood longer so that they may kill tumors better. When the study team did this in the laboratory, they found that this mixture of GPC3-CAR,IL15 and IL21 killed tumor cells better when compared with CAR T cells that did not have IL15 plus IL21 in the laboratory. This study will use those cells, which are called 21.15.GPC3-CAR T cells, to treat patients with solid tumors that have GPC3 on their surface. The study team also wanted to make sure that they could stop the 21.15.GPC3-CAR T cells from growing in the blood should there be any bad side effects. In order to do so, they inserted a gene called iCasp9 into the CO-EXIST T cells. This allows us the elimination of 21.15.GPC3-CAR T cells in the blood when the gene comes into contact with a medication called AP1903. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. This drug will only be used to kill the T cells if necessary due to side effects . The study team has treated patients with T cells that include GPC3. Patients have also been treated with IL-21 and with IL-15. Patients have not been treated with a combination of T cells that contain GPC3, IL-21 and IL-15. To summarize, this study will test the effect of 21.15.GPC3-CAR T cells in patients with solid tumors that express GPC3 on their surface. The 21.15.GPC3-CAR T cells are an investigational product not yet approved by the Food and Drug Administration.
Remote Monitoring in Cancer Care: A Platform Study
This study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. This study may help researchers understand if wearing the device is a better tool than standard vital sign assessment tools done only while at the doctor's office or hospital, and if using the smartphone app is a better tool than standard assessment tools used while in the doctor's office or hospital.
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells
CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Patients With Pediatric Solid Tumors (GAP)
This study enrolls patients who have GPC3-positive solid tumors currently. Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called GAP T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. In preclinical studies, the investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33 that recognizes glypican-3, a proteoglycan found on solid tumors including pediatric liver cancers (GPC3-CAR). This study will test T cells genetically engineered with a GPC3-CAR (GAP T cells) in patients with GPC3-positive solid tumors (currently only enrolling liver tumors). The GAP T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of GAP T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the GAP T cells will help people with GPC3-positive solid tumors. This study enrolls patients who have GPC3-positive solid tumors (currently only enrolling liver tumors).
A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: * Enrollment in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose
Clinical Study on the Safety and Efficacy of B7H3 CAR T Cells in Patients With B7H3 Positive Solid Tumors
This single-arm, single-center investigator-initiated trial (IIT) evaluates the safety, efficacy, and pharmacodynamic (PD)/pharmacokinetic (PK) profiles of CAR-T cells in patients with advanced solid tumors. Eligible subjects are followed until 12 months after infusion or until meeting treatment withdrawal criteria, whichever occurs first.
A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies
This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies
CIBMTR Research Database
The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies. A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries. Objectives: To learn more about what makes stem cell transplants and cellular therapies work well such as: * Determine how well recipients recover from their transplants or cellular therapy; * Determine how recovery after a transplant or cellular therapy can be improved; * Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy; * Determine how access to transplant or cellular therapy for different groups of patients can be improved; * Determine how well donors recover from the collection procedures.
Treating Nectin-4-positive Advanced Solid Tumors With R-Star001 (Nectin-4-CART-IL18)
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety, efficacy, and pharmacokinetics of R-Star001 cell injection in patients with Nectin-4-positive advanced solid tumors.
Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors
The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected called "modified T cells". In the screening part of this study the tumor was found to have a protein called MUC16. This protein is present on about 70% of ovarian cancers. The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard chemotherapy. We also want to find out what effects these modified T cells have on the patient and their cancer.
Phase 1 Trial of AZD6422 in CLDN18.2+ GI Tumors
This is a FTiH, Phase 1 IIT to evaluate the safety, feasibility, cellular kinetics (CK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of AZD6422 in adult participants with advanced or metastatic CLDN18.2+ GI tumors.
C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)
This study is for patients with neuroblastoma, sarcoma, uveal melanoma, breast cancer, or another cancer that expresses a substance on the cancer cells called GD2. The cancer has either come back after treatment or did not respond to treatment. Because there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body fight infection. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. In our last clinical trial we made a gene called a chimeric antigen receptor (CAR) from an antibody that recognizes GD2, a substance found on almost all neuroblastoma cells (GD2-CAR). We put this gene into the patients' own T cells and gave them back to 11 neuroblastoma patients. We saw that the cells did grow for a while, but started to disappear from the blood after 2 weeks. We think that if T cells are able to last longer they may have a better chance of killing GD2 positive tumor cells. Therefore, in this study we will add a new gene to the GD2 T cells that can cause the cells to live longer. T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. In other studies using T cells, investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells to expand and stay longer in the body, and potentially kill cancer cells more effectively. The GD2-C7R T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the largest safe dose of GD2-C7R T cells, and also to evaluate how long they can be detected in the blood and what affect they have on cancer.
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.
A Clinical Study Investigating the Therapeutic Effects and Safety of an Investigational Cell Therapy Given With and Without an Additional Investigational Product in Males With Testicular Cancer or a Form of Cancer That Developed From Sperm
This study is designed to evaluate the safety, efficacy, cellular kinetics, and immunogenicity of Claudin 6 (CLDN6) Chimeric antigen receptor T cell (CAR-T) ± CLDN6 ribonucleic acid-lipoplex (RNA-LPX) in participants born male with relapsed or refractory CLDN6-positive testicular or extragonadal germ cell tumors (GCTs) after prior salvage therapy.
A Biomarker Screening Protocol for Participants With Solid Tumors
Biomarker Screening Protocol for Preliminary Eligibility Determination for Adoptive T-cell Therapy Trials:This is a decentralized, multi-site, US-based biomarker screening study to identify participants who have specific disease indications and tumor expression of target(s) of interest that may inform eligibility for active and future Lyell clinical trials. No investigational treatments will be administered in this non-interventional screening study. Only previously obtained archival tumor tissue will be allowed on this study for biomarker analysis. Fresh tumor biopsies are not permitted on this study. The study will be conducted virtually and participants will utilize telehealth and e-consent modules. If participants tumors express the biomarkers of interest they can be referred to open and enrolling clinical trials. Participation on the screening study does not guarantee enrollment or treatment on an interventional clinical trial.
A Study to Investigate LYL797 in Adults With Solid Tumors
This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.
Hepatic Artery Transfusion of NKG2D CAR-NK Cells Followed by Intravenous Infusion of NKG2D CAR-T Cells to Treat Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments: a Phase I Exploratory Clinical Trial
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and preliminary efficacy of NKG2D CAR-NK cells followed by NKG2D CAR-T cells in patients with advanced solid tumors (e.g.,colorectal cancer) with liver metastases who have failed standard treatments. The study primarily focuses on determining the maximum tolerated dose and recommended phase II dose through sequential cohort dose escalation, while secondarily characterizing the pharmacokinetic parameters and collecting initial efficacy data regarding tumor response. This investigation comprehensively evaluates the pharmacodynamic and pharmacokinetic profile of NKG2D CAR cellular therapy through three primary objectives: (1) systematic monitoring of treatment-emergent adverse events and clinically significant laboratory parameter deviations; (2) assessment of antitumor activity with correlative biomarker analysis; and (3) characterization of cellular kinetics including biodistribution patterns, and mechanistic pathways of therapeutic activity. The protocol clarifies cellular persistence and functional regulation within the tumor microenvironment by longitudinal monitoring of cytokine release and using advanced molecular tracking methods.
National Project on Vaccines, COVID-19 and Frail Patients
This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.
Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer
A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CD70-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
This is an open-label, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or abdominal metastases secondary to malignant solid tumors. The study primarily focuses on determining the maximum tolerated dose and recommended phase II dose through sequential cohort dose escalation, while secondarily characterizing the pharmacokinetic parameters and collecting initial efficacy data regarding tumor response. This investigation comprehensively evaluates the pharmacodynamic and pharmacokinetic profile of MT027 cellular therapy through three primary objectives: (1) systematic monitoring of treatment-emergent adverse events and clinically significant laboratory parameter deviations; (2) assessment of antitumor activity with correlative biomarker analysis; and (3) characterization of cellular kinetics including biodistribution patterns, mechanistic pathways of therapeutic activity, and comprehensive immunogenicity assessment measuring both cellular/humoral immune responses against MT027 cells. The protocol further investigates potential host-versus-product immune reactions through longitudinal monitoring of donor-specific antibodies and cytokine release profiles, while employing advanced molecular tracking methodologies to elucidate cellular persistence and functional modulation within the tumor microenvironment.
An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed/Refractory Solid Tumors
This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.
A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Participants With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression
The goal of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the maximum or recommended dose of A2B530 that is safe for patients * Phase 2: Does the recommended dose of A2B530 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: * Enrollment and Apheresis in BASECAMP-1 (NCT04981119) * Preconditioning Lymphodepletion (PCLD) Regimen * A2B530 Tmod CAR T cells at the assigned dose
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors
The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity. This study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.
CD73/AXL Targeted HypoSti.CAR-T Cells in CD73/AXL Positive Advanced/Metastatic Solid Tumors
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of novel autologous hypoxia-activated CAR-T cell therapy targeting CD73 and AXL ( CD73/AXL.HypoSti.CAR-T) will be evaluated in patients with CD73/AXL antigen positive advanced/metastatic solid tumors. In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses Of CD73/AXL.HypoSti.CAR-T cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD73/AXL.HypoSti.CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product
An observational, long-term follow up (LTFU) study of participants who received an allogeneic CAR T product in a prior clinical study. Participants will be followed for 15 years after their last infusion of an allogenic CAR T cell product.
A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors
Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the status of cell preparation and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. From Day -5 to Day -3, the participant receives a conditioning regimen with cyclophosphamide and antithymocyte globulin. After recovery for two days (Day -2 and Day -1), on Day 0, the participant receives reinfusion of BZE2203 (dose determined according to the dose-escalation requirements). The safety observation period lasts for 28 days, and clinical efficacy is assessed from Day 28 to Day 34. After comprehensive judgment, the second course of cell therapy is selected. Follow-up observations and evaluations are conducted once every three months, with follow-up visits once a year and telephone follow-ups once every two months.
Gene Therapy for Neurofibromatosis Type 2 (NF2) with ST002
This is an open-label, single-arm, dose-escalation pilot study to evaluate the safety, tolerability and preliminary efficacy of ST002 in the treatment of patients with NF2 mutation-related solid tumors. ST002 injection is a gene therapy product designed for NF2. By reinserting the normal XXX gene into genetically deficient tumor cells, the product expresses Merlin. This regulates gene transcription in tumor cells, controls the tumor microenvironment, and inhibits tumor growth and invasion, achieving therapeutic effects.
Allogeneic B7H3 CAR-γδT Cell Therapy for Advanced Solid Tumors
γδT cells can directly recognize non-peptide tumor antigens, such as IPP phosphorylated metabolites, without relying on specific major histocompatibility complexes (MHCs). This unique characteristic leads to a lower risk of graft-versus-host disease (GVHD). The clinical safety of γδT cells in allogeneic tumor therapies has been validated multiple times, highlighting their significant potential in developing universal CAR-T cell therapies. B7H3 (CD276), a member of the B7 negative co-stimulatory molecule family, is minimally expressed or absent in normal tissues but highly expressed in various tumor tissues. As a result, B7H3 is regarded as a highly promising tumor-associated antigen and a universal drug target with substantial therapeutic potential. By utilizing γδT cells as carrier cells, the development of universal B7H3 CAR-γδT cell injections for advanced solid tumors can effectively address risks such as autologous cell preparation failure and treatment delays. This innovative approach offers a highly efficient solution for solid tumor treatment and holds great promise for advancing immunotherapy in this field
Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors
This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.
Anti-GD2 CAR T Cells in Pediatric Patients Affected by High Risk and/or Relapsed/Refractory Neuroblastoma or Other GD2-positive Solid Tumors
The purpose of this study is to test the safety and efficacy of GD2-CART01, a CAR T cell treatment targeting GD2 in paediatric or young adult patients with High Risk and/or relapsed/refractory Neuroblastoma. A small exploratory cohort of patients with GD2-positive tumors other than Neuroblastoma has also been included.
TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)
The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).
Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors
Study of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors
MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3. It is a next-generation, ready-to-use CAR-T product that can be used immediately and promptly for patients to solve the problem of unmet medical needs for a large number of patients who have a demand for CAR-T therapy but cannot receive it due to the common reasons of long production cycle, insufficient production capacity, and incompatibility of patients' T cells with the production conditions. In addition, the expected medical cost of allogeneic CAR-T cells is significantly lower, which can greatly alleviate the economic burden on patients. MT027 is prepared by expressing a chimeric antigen receptor (CAR) targeting B7H3 on gene-edited T cells through gene modification technology. MT027 products targeting the B7H3 target developed by Moxing Biotech avoid the potential graft-versus-host disease (GvHD) and host anti-graft reaction (HvGR) caused by the interaction between exogenous T cells and the patient's immune system, and have shown good safety and efficacy in recurrent high-grade glioma in the initial phase.
A Clinical Study of CHT101 in CD70-Positive Advanced Solid Tumors
Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.
A Study of MT027 in Patients with Pleural Malignant Tumors
This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy.. Subjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.
A Clinical Study of CHT102 in Mesothelin Positive Advanced Solid Tumors
Objectives of Study：In this study investigators plan to evaluate the safety and efficacy of MSLN-targeting Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) in the treatment of MSLN-positive advanced solid tumors.
Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)
CAR-T is a pioneering cancer treatment which has found success in some cancers. This treatment is made first by taking blood cells from the patient. Then in the lab, an artificial protein - a Chimeric Antigen Receptor (CAR), is grafted on the surface of immune cells. The modified cells, which are readministered to the patient, have enhanced abilities to target and destroy cancers than unmodified immune cells. Currently approved CAR-T can only be used autologously. i.e. the patient will receive CAR-T treatment made from their own cells. This is because current CAR-T treatment uses αβ T cells - a type of immune cell which are largely non-transferable between individual human beings due to the high risk of Graft-versus-Host Disease. However, autologous CAR-T comes with many limitations. A lengthy, manufacturing process follows after the patient donates their own blood, accompanied by a high risk of manufacturing failure, which can be attributed to the cell quality from cancer patients undergoing stressful anti-cancer therapy. CytoMed Therapeutics pioneers a new CAR-T treatment (CTM-N2D) which may confer some benefit over current CAR-T treatment. CTM-N2D uses a subtype of immune cell -- γδ T cell. Secondly, the CAR on CTM-N2D targets a surface antigen called NKG2DL which are commonly present in many cancer. These two features may confer a safer product profile, of better quality and may be efficacious in cancers where previous CAR-T treatments has not. The phase I clinical trial of CTM-N2D will be conducted at the National University Hospital, Singapore. The objective of this clinical trial is to determine the optimal dose of CTM-N2D, and to investigate its safety and tolerability. The subjects of the clinical trial will also be investigated for their tumour response to CTM-N2D. CTM-N2D has undergone preclinical studies. Relevant data from other clinical trials are also used to infer the expected outcome, and strategies of management of this clinical trial. The institution's ethical review board must give its approval before the study may begin. An independent Data Safety Monitoring Board monitors the safety aspect of this trial.
Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and pancreatic cancer. The CLDN18.2/PD-L1 dual-targeting CAR-T will be investigated in patients with CLDN18.2-positive advance solid tumors.
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
This study is in 2 parts. The main aims of the 1st part of the study are to check if people with advanced solid tumors or cancers in the immune system (lymphomas) have side effects from TAK-981, and to check how much TAK-981 they can receive without getting side effects from it. The main aims of the 2nd part of the study are to learn if the condition of people with specific cancers improves after treatment with TAK-981. Another aim is to check for side effects from TAK-981. In the 1st part of the study, participants will receive TAK-981. In the 2nd part of the study, participants with specific tumor types will receive TAK-981 at the recommended phase 2 dose determined during the 1st part of the study. In both parts of the study, participants can receive TAK-981 for up to 1 year or longer if their condition stays improved. Participants will receive TAK-981 through vein.
Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors
CAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. In this study, the PD-L1 inhibitory signal was transformed into an activation signal in the tumor microenvironment, and enhanced the killing activity and survival ability of CAR-T cells. The HER-2/PD-L1 dual-targeting CAR-T will be investigated in patients with HER2-positive solid tumors, and all enrolled subjects will receive HER2/PD-L1 CAR T cells via intravenous or thoracic/peritoneal cavity infusion.
A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors
This clinical study is to investigate the safety and tolerability of CCT303-406 CAR modified autologous T cells (CCT303-406) in subjects with relapsed or refractory stage IV metastatic HER2-positive solid tumors.
A Study of CCT301-59 CAR T Therapy in Adult Subjects With Recurrent or Refractory Solid Tumors
This clinical study is to investigate the safety and tolerability of CAR modified autologous T cells (CCT301-59) in subjects with recurrent or refractory solid tumors.
Genetically Modified T Cells Treating Malignant Tumors
To observe the safety, tolerability and initial effectiveness of gene modified T cell therapy in patients with malignant tumors in First Affiliated Hospital of Zhengzhou University, China.
Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Phase 1 Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors
This is a first-in-human, single-arm, open-label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity and preliminary efficacy of UCMYM802 (Circular mRNA encoding Anti-Mesothelin CAR-T) injection in patients with Mesothelin-positive advanced malignant solid tumors.
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of advanced NKG2DL+ solid tumors.
Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-CDH17 CAR-T cell injection in patients with CDH17-positive advanced malignant solid tumors.
Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid
The purpose of this study is to evaluate the safety and tolerability of different doses and administration regimens of Stimotimagene copolymerplasmid in patients with histologically confirmed diagnosis of solid tumor and/or its metastases.
Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Release for Advanced Solid Tumors
To study the safety and clinical effects of intratumor injecting CpG-ODN and in situ release of tumor antigen by interventional ablation or drug-eluting beads to treat advanced solid tumors.
Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers
The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.
EGFR/B7H3 CAR-T on Lung Cancer and Triple Negative Breast Cancer
This study is a single-arm, open, exploratory clinical study to evaluate the safety and efficacy of EGFR/B7H3 CAR-T in patients with EGFR/ B7H3-positive advanced solid tumors (lung cancer and triple-negative breast cancer)
U87 CART in Treatment of Advanced Solid Tumor
This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .
A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric Antigen Receptor in Children and Young Adults With GD2+ Solid Tumors
Background GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on osteosarcomas and some other sarcomas. T cells expressing 1st generation anti-GD2 chimeric antigen receptors (CARs) were safe and mediated modest antitumor activity in some patients with refractory neuroblastoma. A 3rd generation anti-GD2-CAR (GD2-CAR.OX40.28.z.ICD9) has been produced and holds promise for increased activity compared to the 1st generation GD2-CAR already studied in clinical trials. As an added safety measure, the vector includes a suicide switch comprising a caspase dimerization domain (ICD9) that can be activated by a small molecule to induce death of the genetically engineered cells if they were induce untoward toxicity. Objectives Primary:Determine the feasibility of producing anti GD2-CAR cells meeting the established release criteria and to assess the safety of administering escalating doses of anti-GD2-CAR engineered T cells in children and young adults with GD2+ solid tumors, including neuroblastoma, following cyclophosphamide-based lymphodepletion. Secondary: 1. Determine if administration anti-GD2-CAR engineered T cells mediate antitumor effects in children and young adults with GD2+ solid tumors; 2. Measure persistence of adoptively transferred anti-GD2-CAR T cells and correlate this with antitumor effects; 3. Extend information regarding the prevalence and intensity of GD2 expression in non-neuroblastoma, non-osteosarcoma solid tumors in children and young adults; 4. If unacceptable toxicity occurs that is possibly, probably or likely related to anti-GD2-CAR T cells, assess the capacity for AP1903, a dimerizing agent, to mediate clearance of the genetically engineered cells and resolve toxicity; and 5. Assess toxicity of AP1903 if administered to mediate clearance of anti-GD2-CAR T cells. Eligibility Patients 1-35 years of age, at least 15 kg, with osteosarcoma or a GD2+ solid tumor (including neuroblastoma) that has recurred after or not responded to standard therapy and is deemed incurable by standard therapy. Design After apheresis to collect T cells for transduction, patients receive cyclophosphamide 1800mg/m(2)/d as a lymphodepleting regimen. A phase I cell dose escalation scheme will used at 4 dose levels (1 x 10(5) transduced T cells/kg; 1 x 10(6) transduced T cells/kg; 3 x 10(6) transduced T cells/kg; and 1 x 10(7) transduced T cells/kg), using a standard 3 plus 3 dose escalation design. An expanded group of a total of 12 patients will be treated at the highest dose, comprising at least 6 osteosarcoma patients. Patients will be monitored for toxicity, antitumor effects and persistence of anti-GD2-CAR T cells. Patients with a PR, SD may receive a 2nd cycle at the next higher dose level a minimum of 60 days following completion of the first cycle if eligibility criteria are met. A maximum of 36 patients may be treated on this study. Given that there is likelihood that some patients with non-osteosarcoma will not meet the criteria for GD2 expression to be eligible for enrollment, up to 72 subjects will be screened to enroll a maximum of 36 patients for treatment. Up to 2-3 patients will be accrued per month, and therefore this study may require up to 2-3 years to complete enrollment and treatment.
Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors
In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive an initial dose of pan-T booster co-expressing MSLN CAR T cells at 1×10\^6 cells/kg based on the basic principle of dose escalation design, in order to evaluate the safety, feasibility, pharmacokinetics/pharmacodynamics, and efficacy of pan-T booster co-expressing MSLN CAR T cell in vivo.
Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors
This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns.
An Exploratory Study by Fast CAR T Cells
The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered.
A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors
This is a single-center, open-label clinical study of anti-HER2-CAR-T cells for HER2+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include HER2+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-HER2-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
An Exploratory Study on the Treatment of Advanced Solid Tumors by Fast CAR T Cells
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of fast autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies in patients with solid tumors.
Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 and CTLA-4 nanobodies (αPD1/CTLA-4-MSLN-CAR T cells) in patients with solid tumors.
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors
This trial is an open-label, single-arm clinical study. The main purpose is to verify the safety and efficacy of CAR-T cell preparations in the treatment of CEA-positive advanced malignant tumors, and to obtain the recommended dose and infusion scheme of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignant tumors.
Dual-targeting VEGFR1 and PD-L1 CAR-T for Cancers Patients With Pleural or Peritoneal Metastases
Serosal cavity metastases of malignant tumor seriously affects the quality of life and survival time of patients with cancers in advanced stage. VEGFR1 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors and their metastases. The VEGFR1/PD-L1 dual-targeting CAR-T will be investigated in cancer patients with serosal cavity metastases.
EpCAM CAR-T for Treatment of Advanced Solid Tumors
This study is for patients that have nasopharyngeal carcinoma, breast cancer, gastric cancer and other solid tumors. As epithelial cell adhesion molecule (EpCAM) is a well characterized molecule that is closely with poor prognosis and tumor metastasis and invasion. Many therapies targeting EpCAM have shown benefits for cancer patients. This study is to determine the safety of the engineered T cells armed with chimeric antigen receptor (CAR-T) recognizing EpCAM. At the same time, efficacy is to be evaluated by the criteria of RECIST. The EpCAM CAR-T were produced by lentiviral transduction of the novel 2nd generation of CAR genes. Different cohorts of patients receive EpCAM CAR-T with a dose-escalating manner. This study is to find the largest dose of EpCAM CAR-T, to learn what the adverse effects are and to find out whether this experimental intervention might help patients with nasopharyngeal carcinoma, breast cancer and other EpCAM positive solid tumors.
NKG2D/CLDN18.21 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumor
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors
This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic solid tumors, and obtain recommended doses and infusion patterns.
A Clinical Study to Evaluate B4T2-001 CAR T Cells in the Treatment of Advanced Solid Tumors
This is a first in human (FIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of B4T2-001 Autologous CAR T cells in subjects with advanced solid tumors including but not limited to advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, advanced pancreatic cancer, advanced non-small cell lung cancer (NSCLC), colorectal cancers (CRC) and metastatic breast cancer that tests positive for BT-001 target antigen according to Immunohistochemistry (IHC).
Repeat Intravenous Infusions of B4T2-001 CAR-T Without Lymphodepleting Chemotherapy for Solid Tumors
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of autologous B4T2-001 CAR-T in subjects with advanced solid tumors including but not limited to advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, advanced pancreatic cancer, advanced non-small cell lung cancer (NSCLC), colorectal cancers (CRC) and metastatic breast cancer that tests positive for BT-001 target antigen according to Immunohistochemistry (IHC). The trial builds off first-in-human results from pilot study per clinicaltrials.gov ID: NCT05621486 to administer multiple infusions of B4T2-001 CAR-T without the need to give preparative chemotherapy (lymphodepletion).
MVX-ONCO-1 in Patients With Solid Tumor
The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.
A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CD70-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
A Clinical Research About CD70-positive Advanced/Metastatic Solid Tumors Treated by CD70-targeted CAR-T
As a phase I clinical research，this study plans to evaluate the safety and tolerability of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic solid tumors, and obtain recommended doses and infusion patterns.
A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors
This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors.
Universal Dual-target NKG2D-NKp44 CAR-T Cells in Advanced Solid Tumors
This is a single arm, open-label, multi-center, phase I study to evaluate the safety, tolerability, preliminary efficacy, pharmacodynamics and immunogenicity of universal chimeric natural killer receptor modified T-cells (CNK-UT) targeting NKG2D-Ligands and NCR2-Ligands with or without lymphodepletion in advanced solid tumors.
Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of XKDCT086 (iPD-1-Claudin18.2-CAR-T) in Claudin 18.2 Positive Advanced Solid Malignant Tumors: a Single Center, Single Arm, Dose-increasing Trial
The goal of this clinical trial is to assessing the safety and tolerability of XKDCT086 cells against recurrent or refractory solid tumors with Claudin18.2 positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting Claudin18.2.
CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive advanced/metastatic solid tumors . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Study of αPD1-MSLN-CAR T Cells to Evaluate the Safety, Tolerability, and Effectiveness for Patients With MSLN-positive Advanced Solid Tumors
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.
Phase I/II Study of αPD1-MSLN-CAR T Cells in MSLN-positive Advanced Solid Tumors
An open, multicenter, phase I/II study to evaluate the safety, tolerability, and effectiveness of αPD1-MSLN-CAR T cells in patients With MSLN-positive advanced solid tumors
Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors
An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345
A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors
UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of UCLM802 (Anti-Mesothelin CAR-T) cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
A Study of IMC008 for Advanced Solid Tumors
An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.
Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with previously treated, locally advanced or metastatic solid tumors which are HER2 amplified/overexpressed.
Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer
This is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.
PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer
This exploratory clinical study aims to assess the safety and preliminary efficacy of an immunotherapy using PD-1 knockout anti-MUC1 CAR-T cells in the treatment of advanced MUC1-positive breast cancer
MSLN-targeted CAR-T Cells in Solid Tumors.
This study aims to explore the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cells in subjects with Mesothelin-positive advanced malignant solid tumors.
UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of UCLM802 (Anti-Mesothelin CAR-T) cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and efficacy of novel Mesothelin CAR-T in patients with Mesothelin-positive advanced refractory solid tumors.
A Study of RD14-01 in Patients With Advanced Solid Tumors
This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.
A Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T-cell (CART) in the Treatment of Solid Tumors
This is a single-arm, investigator-initiated exploratory study.The study is designed to evaluate the safety and the tolerability of HER2-E-CART cells for the treatment of patients with HER2-positive, refractory advanced solid tumors in three dose groups: low, medium and high.
NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.
A Study of RD14-01 in Patients With Advanced Solid Tumors
This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.
QUALITOP - Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy, an Open Smart Digital Platform for Personalized Prevention and Patient Management
An increasing number of cancer patients are eligible to receive immunotherapy. Efficacy and tolerance have been demonstrated in multicentre randomized clinical trials with positive results. However, real-life experience differs from clinical trial results, especially regarding the management of potential adverse events. HR-QoL (Health Related Quality of Life) is one of the components of QoL (Quality of Life) in its broad acceptation and is certainly the only one usually collected in trials while little is known about QoL in cancer patients treated in the 'real-world'. QUALITOP partners intend to bring together all relevant longitudinal information present in large heterogeneous data (big data) to estimate patient QoL and find surrogate markers of QoL and its evolution. Within the QUALITOP consortium, 5 countries will collect prospective clinical and QoL data and also retrospective clinical data, and share it. This project will enable collecting, managing, sharing, modelling, processing, and exploiting big data on QoL. Furthermore, beyond the description of QoL, analytical tools (including causal inference methods and machine learning) are needed to understand the determinants of QoL and their complex relationships with irAEs (immune related Adverse Events) in a big-data context where standard statistical techniques would be limited. Artificial intelligence and causal models may be applied and developed to empower the patient, prevent adverse medical conditions, and promote QoL. The created knowledge will enable proposing guidelines for promoting better QoL. QUALITOP aims at identifying the determinants of health status regarding immunotherapy-related adverse events (IR-AEs, such as toxicities) depending on the patient's profile in a real-world context. The richness of QUALITOP is in the diversity of the experts who will collaborate in it. Clinicians involved in the care (thus the health status of the patients) will collaborate with psychologists and sociologists to understand and integrate complementary dimensions of QoL related to immunotherapy. Experts in pharmacovigilance and pharmacists will investigate the IR-AEs and their associations with patient behaviour and non-drug consumption. Epidemiologists, data scientists (including bioinformaticians and biostatisticians) and economists will extract information from the data and develop simulation models to produce knowledge. The project will take place in close relation with patient associations that will interact with experts to design the analyses, interpret their results, and proceed to their dissemination. The main objective is to collect data of patients receiving immunotherapy in order to describe its impact in their quality of life. * Create the first real-life cohort of cancer patients treated with immunotherapy within a context of multidimensional management (with data on clinical information, health-related QoL (HR-QoL), IR-AEs, drug consumption, lifestyle, and administrative data). * Accelerate knowledge directed to different stakeholders (patients, relatives, clinicians, pharmacists, health authorities, and the general public) for a better understanding of the determinants of QoL and its optimization after immunotherapy through the development of innovative analytic tools (artificial intelligence and causal models). * Produce policies and recommendations to improve patients QoL and participate in the implementation of the SDGs (Sustainable Development Goals) for 4P medicine (Predictive, Preventive, Personalized, Participative) in immunotherapy for cancer patients.
Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
TGFβR-KO CAR-EGFR T Cells in Previously Treated Advanced EGFR-positive Solid Tumors
Chimeric antigen receptor modified T (CART) cell therapy has been identified as a breakthrough therapy in hematologic malignancies. However, CART cell therapy yielded no satisfactory efficacy data in the study of solid tumors. One of major challenges is the complicated immunosuppressive tumor microenvironment (TME) in solid tumors. It has been reported that transforming growth factor-β (TGF-β) is one of the major regulatory factors in the TME. In this study, we construct CAR-EGFR-TGFβR-KO T cell by knocking out TGF-β receptor Ⅱ through CRISPR/Cas9 in order to study the anti-tumor activities and safety profiles of CAR-EGFR-TGFβR-KO T cell in previously treated advanced EGFR positive solid tumors.
αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.
Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies
This phase I trial studies the side effects and best dose of genetically modified T-cell therapy in treating patients with receptor tyrosine kinase-like orphan receptor 1 positive (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), stage IV non-small cell lung cancer (NSCLC), or triple negative breast cancer (TNBC) that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Genetically modified therapies, such as ROR1 specific chimeric antigen receptor (CAR) T-cells, are taken from a patient's blood, modified in the laboratory so they specifically may kill cancer cells with a protein called ROR1 on their surfaces, and safely given back to the patient after conventional therapy. The "genetically modified" T-cells have genes added in the laboratory to make them recognize ROR1.
B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors
This is a clinical study to evaluate the safety and efficacy of CAR-T cells in the treatment of patients with advanced solid tumors in China.
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.
GD2/PSMA Bi-specific CAR-T Cell Therapy
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/PSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2/PSMA bi-specific CAR-T cells and their persistency in patients.
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of advanced NKG2DL+ solid tumors.
A Study of Anti-Lewis Y Chimeric Antigen Receptor-T Cells (LeY-CAR-T) in Patients With Solid Tumours
This clinical trial is an open-label, single-centre, phase I study designed to investigate the safety and tolerability of a single infusion of autologous peripheral blood T-lymphocytes transduced with the anti-LeY-scFv-CD28-ζ vector (LeY CAR T-cells) The primary aim of the trial is to evaluate the safety and tolerability of LeY CAR T cells in patients with Lewis Y antigen-expressing, advanced solid tumours. The secondary aim of the trial is to assess the anti-tumour activity of LeY CAR T cells in patients with LeY antigen-expressing, advanced solid tumours. Patients aged 18 years or older with advanced solid tumours have consented to pre-screening that allows their tumours to be assessed for LeY expression by immunohistochemistry. Patients whose tumours test positive for LeY were then able to proceed to eligibility screening and, if found to fulfil the eligibility criteria, were registered in the study. The study involves an initial dose escalation phase followed by an expansion phase.
Safety and Efficacy of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors
This study is a single-center exploratory clinical trial. It is estimated that 9-24 subjects will be enrolled. The "3+3" dose escalation design is adopted. The main purpose is to evaluate the safety of RD133 in the treatment of subjects with relapsed or refractory MSLN-positive solid tumors and explore the Recommend phase II dose of RD133 in the treatment of patients with relapsed/refractory MSLN-positive solid tumors.
MSLN STAR-T Cells in the Treatment of Advanced Malignant Solid Tumors
This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of MSLN STAR-T cell immunotherapy in the treatment of advanced malignant solid tumors.
Metoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
The aim of this prospective study is to evaluate the feasibility and efficacy of metoprolol, a beta-1 adrenergic receptor blocker, in the treatment of cytokine release syndrome (CRS) caused by chimeric antigen receptor T (CAR T) cell infusions, its effects on the serum levels of Interleukin-6 (IL-6) and other cytokines.
Clinical Trial to Evaluate the Safety and Efficacy of IM96 CAR-T Cells Therapy in Patients With Advanced Digestive System Neoplasms
This is a open-label, single center to determine the efficacy and safety of IM96 CAR-T cells in Patients With Advanced Digestive System Neoplasms
RD07 Cell Injection in the Treatment of Patients With Advanced Claudin18.2 Positive Solid Tumors
IP: RD07 cell injection; Target disease：solid tumor; Protocol design： Single arm, open label, dose increasing design. The experiment was divided into two stages: dose increasing stage and dose extension stage. After the completion of the dose escalation phase (9 or 12 cases) and the conclusion of safety, the investigator can select the appropriate dose group according to the safety, tolerance, and treatment response to enter the dose expansion phase. Dose extension stage (24 and 27 cases) according to the indications in the crowd into three queues: respectively for the integration of a stomach and the stomach esophagus adenocarcinoma, pancreatic cancer and other solid tumor, expand stage each queue number of cases can be determined by the actual filter and into the group of patients, no separate regulation, but two phase of the total case must not exceed 36 cases.
Clinical Trial to Evaluate the Safety and Efficacy of IM92 CAR-T Cells Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma
This is a open-label, single center to determine the efficacy and safety of IM92 CAR-T cells in Patients With advanced gastric/esophagogastric combination adenocarcinoma that has failed at least second-line therapy and advanced pancreatic cancer that has failed at least first-line therapy.
A Clinical Trial of TAA06 Injection in Advanced Solid Tumors
B7-H3 (also known as CD276) is widely expressed on the surface of a variety of malignancies solid tumors, while it rarely or even doesn't express on normal tissues. Therefore, B7-H3 is an ideal target for chimeric antigen receptor (CAR) T cells therapy. TAA06 injection is a CAR T injection targeting B7-H3. This is a phase I clinical study with the primary objective of evaluating the safety and tolerability of TAA06 injection in subjects with TAA06-positive advanced solid tumors. The secondary objectives are as follows: to evaluate the distribution, proliferation and persistence of B7-H3-targeted CAR T cells after injection of TAA06 in subjects; to preliminarily evaluate the efficacy of TAA06 injection in subjects with TAA06-positive advanced solid tumor.
An Exploratory Clinical Study of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors
This study is a single-center exploratory clinical trial. It is estimated that 9-24 subjects will be enrolled. The "3+3" dose escalation design is adopted. The main purpose is to evaluate the safety of RD133 in the treatment of subjects with relapsed or refractory MSLN-positive solid tumors and explore the Recommend phase II dose of RD133 in the treatment of patients with relapsed/refractory MSLN-positive solid tumors.
NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors
The primary objective of this study is to evaluate the safety and clinical activity of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.
Anti-mesothelin CAR-T Cells With Advanced Refractory Solid Tumors
The goal of this clinical trial is to study the safety, efficacy, and pharmacokinetics of mRNA-engineered anti-Mesothelin (MESO) Chimeric Antigen Receptor T-Cell (CAR-T cells) therapy in patients with mesothelin expression-positive, advanced solid tumors that have failed at least first-line or second-line therapy.
Investigator Initiated Phase 1 Study of TBI-1201
Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid tumors.
Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors
This is an open-labeled, single-armed and prospective study, patients with advanced malignant solid tumors will be given with SL22P autologous CAR - T/CAR-TILs cells. The aim of the study is to evaluate the safety and efficacy of SL22P CAR-T cells, including the adverse reaction, pharmacokinetics, and the outcomes of patients.
Clinical Study of CD276 Targeted Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With CD276 Positive Advanced Solid Tumor
Cd276 (B7-H3) is an ideal target for car-t treatment because of its high expression on the surface of neuroblastoma, osteosarcoma, gastric cancer and lung cancer cells, but not in normal peripheral cells or tissues. In conclusion, car-t cell therapy has achieved exciting results in blood tumors, but it has been stopped in solid tumor. The main reason for the poor effect is the existence of tumor microenvironment of solid tumor, which inhibits the chemotaxis and infiltration of car-t cells to tumor site. Therefore, in this clinical experiment, we will explore the best model of car-t therapy for solid tumor by intravenous and local tumor injection, which will bring new hope to patients with osteosarcoma, neuroblastoma and gastric cancer
Autologous CAR-T/TCR-T Cell Immunotherapy for Solid Malignancies
This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.
CD276 CAR-T for Patients With Advanced CD276+ Solid Tumors
This study is a clinical study of CD276 CAR-T in the treatment of patients with advanced solid tumors. The purpose is to evaluate the safety and effectiveness of targeting CD276 auto-chimeric antigen receptor T cells in the treatment of CD276-positive advanced solid tumors.
Interventional Therapy Sequential With the Fourth-generation CAR-T Targeting Nectin4/FAP for Malignant Solid Tumors
According to the high expression of tumor cell-associated antigen Nectin4 in patients with solid tumors such as non-small cell lung cancer, breast cancer, ovarian cancer, bladder cancer, and pancreatic cancer, and in order to target FAP-positive CAFs in the tumor-associated stroma, the Intravenous minimally invasive surgery combined with intratumoral injection of Nectin4/FAP-targeted fourth-generation CAR-T cells (expressing IL7 and CCL19, or IL12) are used to treat Nectin4-positive advanced malignant solid tumors, maximally eliminating residual cancer cells and preventing recurrence.
NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors
The primary objective of this study is to evaluate the safety and clinical activity of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.
Study of CRISPR-Cas9 Mediated PD-1 and TCR Gene-knocked Out Mesothelin-directed CAR-T Cells in Patients With Mesothelin Positive Multiple Solid Tumors.
Multiple solid tumors have positive targets of mesothelin expressed on the surfaces of the tumor cells, we use the technique of CRISPR-Cas9 to knocked out the PD-1 and TCR of chimeric antigen receptor (CAR) T cells to effect the immuno-microenvironment around tumors.
αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.
αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
The aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines CAR T cells and IgT cells to treat sarcoma.
Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.
This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers. Comparison will be made to historical data. General safety and efficacy using RECIST 1.1 and Immune-Related Response Criteria as well as ECOG performance will be utilized.
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.
A Clinical Study on the Safety and Efficacy of CAR-T Therapy for the TM4SF1- and EpCAM-positive Solid Tumors
* Transmembrane 4 L Six Family Member 1 (TM4SF1) and Epithelial cell adhesion molecule (EpCAM) are both highly expressed in many epithelial-derived solid tumors. * The Chimeric Antigen Receptor T-cells (CAR-T) that target TM4SF1 or EpCAM have been generated respectively in our good manufacturing practices (GMP) facility and their anti-tumor effects have been demonstrated in multiple in vitro and in vivo studies. * Clinical studies are proposed here to evaluate the anti-tumor activity of these cell therapy products for treatment of patients with TM4SF1 or EpCAM positive tumors. In this study, the safety, tolerance, and preliminary efficacy of CART-TM4SF1 and CART-EpCAM cells will be examined inpatients with refractory/recurrent advanced pancreatic cancer, colorectal cancer, gastric cancer or lung cancer. And 9 patients for each cancer will be evaluated. * Clinical and immunological responses will be evaluated about 30 days and last up to 2 years after CAR-T cell infusion.
Haplo / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells for Relapsed or Refractory Solid Tumour
This clinical trial is an open-label, single-centre, dose escalation, phase I study designed to investigate the safety and tolerability of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted Gamma Delta (γδ) T Cells (CTM-N2D) in Subjects with Relapsed or Refractory Solid Tumour. The study objectives of this phase I study are to determine the safety, activity and the safe dose of haploidentical or allogeneic NKG2DL-targeting chimeric antigen receptor-grafted γδ T cells given four times weekly in patients with relapsed or refractory solid tumors of different types.
Intervention of CAR-T Against Cervical Cancer
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.
Study of PD-1 Gene-knocked Out Mesothelin-directed CAR-T Cells With the Conditioning of PC in Mesothelin Positive Multiple Solid Tumors
Multiple solid tumors have positive targets of mesothelin expressed on the surfaces of the tumor cells, the investigators use the technique of CRISPR-Cas9 to knocked out the PD-1 of the chimeric antigen receptor (CAR) T cells with the combination of Pretreatment by Paclitaxel and Cyclophosphamideto to effect the immuno-microenvironment around tumors.
Investigator Initiated Phase 1 Study of TBI-1301
Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors.
CAR T and PD-1 Knockout Engineered T Cells for Esophageal Cancer
The study is to assess the safety and efficacy of the immunotherapies using anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells in the treatment of patients with advanced esophageal cancer.
PD-1 Antibody Expressing mesoCAR-T Cells for Mesothelin Positive Advanced Solid Tumor
This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to target mesothelin and express PD-1 antibodies in adult patients with advanced recurrent or refractory malignant solid tumors, which were positive expression of mesothelin.
CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor
This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies (CTLA-4 and PD-1) and chimeric antigen receptor targeting epidermal growth factor receptor (EGFR-CAR) in adult patients with EGFR positive, advanced recurrent or refractory malignant solid tumors.
CTLA-4 and PD-1 Antibodies Expressing Mesothelin-CAR-T Cells for Mesothelin Positive Advanced Solid Tumor
This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies (CTLA-4 and PD-1) and chimeric antigen receptor targeting mesothelin (mesoCAR-T) in adult patients with mesothelin positive, advanced recurrent or refractory malignant solid tumors.
CTLA-4 and PD-1 Antibodies Expressing MUC1-CAR-T Cells for MUC1 Positive Advanced Solid Tumor
This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies (CTLA-4 and PD-1) and chimeric antigen receptor targeting MUC1 in adult patients with MUC1 positive, advanced recurrent or refractory malignant solid tumors.
A Phase I Study of Systemic Gene Therapy With SGT-94 in Patients With Solid Tumors
This is a Phase I study designed to evaluate the safety and maximum tolerated dose (MTD) of SGT-94, a novel, tumor-targeted, systemic gene therapy agent for cancer. In addition, we will look for evidence of RB94 expression within tumor tissue after systemic administration of SGT-94.
PD-1 Antibody Expressing CAR T Cells for Mesothelin Positive Advanced Malignancies
This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or refractory malignant tumors.
CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.
Phase I/II Study of Anti-Mucin1 (MUC1) CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor
The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for patients with relapsed or refractory solid tumor.
PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor
To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat advanced cancer. Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.
PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)
Objectives: To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.
Phase II/Pilot Study of 2nd Generation Anti-CEA Designer T Cells in Adenocarcinomas
T cells can penetrate virtually every biologic space and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remis-sions of cancer. However, T cells are easily tolerized to self or tumor antigens and "immune surveillance" has manifestly failed in every cancer that is clinically apparent. It is the goal of these studies to supply the specificities and affinities to patient T cells without regard for their "endogenous" T cell receptor repertoire, directed by antibody-defined recognition to kill malignant cells based on their expression of antigen. We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to yield "designer T cells" from normal patient cells. This extends the approach of Anderson, Rosenberg and co-workers to introduce or augment expression of genes in patients' T cells in a therapeutic setting. Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an effective, self-sustaining immune response. It therefore becomes of paramount interest to extend these studies to a human system of widespread clinical relevance to explore the clinical potential of this new technology. The target antigen for these studies is carcinoembryonic antigen (CEA) which is predominantly expressed on tumors of the colon and rectum, breast, pancreas and other sites.
Safety Study of Adenovirus/PNP Coupled With Fludarabine Phosphate to Treat Solid Tumors
This study will test whether it is possible to introduce new genetic material into a small portion of a tumor and have the product of the new gene not only kill those tumor cells that were infected initially, but also the surrounding tumor cells as well with limited or no harm to the patient. The desired effects of this approach are achieved by focusing potent chemotherapies directly within the tumor itself and, as a result, avoiding injury to the remainder of the body. In this study, we will use two components, the first of which is a virus, known as an adenovirus, that has been crippled (i.e., it cannot make more of itself) and loaded with a bacterial gene called E. coli purine nucleoside phosphorylase (PNP). Adenoviruses are considered to be relatively safe vehicles for gene delivery and are presently being used in numerous human trials and therapies worldwide, including a head and neck cancer therapy approved for use outside the United States. The loaded adenovirus will be used to deliver the PNP gene directly into a tumor in patients. This gene is not expected to have an effect itself. However, the gene produces PNP inside the tumor and this protein will activate the second component of the therapy, a drug called fludarabine phosphate, which is approved by the FDA for certain types of blood-cell cancers, but has not been shown to be effective against most solid tumors. The proposed therapy gives the patient several infusions of fludarabine following the injection of the virus carrying the PNP gene and, as the fludarabine enters the tumor, it will be converted by PNP into a second compound, fluoroadenine. Numerous studies in mice and rats have shown that fluoroadenine is a very potent anti-cancer agent and that it will kill the tumor cells where it is made as well as those in the immediately surrounding area.
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
Gene Therapy and Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
RATIONALE: Gene therapy may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy together with chemotherapy in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.
Safety and Efficacy of Adenoviral Endostatin in the Treatment of Advanced Solid Tumor
The growth and metastasis of solid tumors are dependent on angiogenesis. Endostatin, the C-terminal proteolytic fragment of collagen XVIII, is an effective endogenous angiogenesis inhibitor in cancer therapy in mice. Applied for clinical studies in solid tumor, however, recombinant human endostatin protein, difficulties in a large-scale production of the recombinant endostatin protein, and the cumbersome daily administration. Up to now, its clinical application has been hampered by those matters. We herein constructed a adenoviral vector ecoding human endostatin. This study will test the safety and efficacy of recombinant human endostatin adenovirus (Ad-rhE) in the treatment of patients with advanced solid tumors.