NCT07758673

A Phase 1 Study to Evaluate BAFFR-Targeting CAR T Cells for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Study Summary

This phase I trial tests the safety and side effects of B-cell activating factor receptor (BAFFR) chimeric antigen receptor (CAR) T cells and how well they work in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell lymphoblastic lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy, such as BAFFR-CAR T cells, is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving BAFFR-CAR T cells may be safe, tolerable and/or effective in treating patients with relapsed or refractory B-cell ALL and B-cell lymphoblastic lymphoma.

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Interventions

Autologous BAFFR-targeting CAR T CellsBIOLOGICAL
Given IV
Biospecimen CollectionPROCEDURE
Undergo blood and CSF specimen collection
Bone Marrow AspirationPROCEDURE
Undergo bone marrow aspiration and biopsy
Bone Marrow BiopsyPROCEDURE
Undergo bone marrow aspiration and biopsy
Bridge TherapyPROCEDURE
Receive bridging therapy
Chest RadiographyPROCEDURE
Undergo chest x-ray
Computed TomographyPROCEDURE
Undergo CT or PET/CT
CyclophosphamideDRUG
Given IV
Echocardiography TestPROCEDURE
Undergo ECHO
FludarabineDRUG
Given IV
LeukapheresisPROCEDURE
Undergo leukapheresis
Magnetic Resonance ImagingPROCEDURE
Undergo brain MRI
Multigated Acquisition ScanPROCEDURE
Undergo MUGA
Positron Emission TomographyPROCEDURE
Undergo PET/CT
Ultrasonographic ElastographyPROCEDURE
Undergo liver ultrasonographic elastography

Study Locations

FacilityCityStateCountry
City of Hope Medical CenterDuarteCaliforniaUnited States
City of Hope at Irvine LennarIrvineCaliforniaUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: August 28, 2026