NCT00968760

CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies

Study Summary

Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. The goal of this clinical research study is to learn if an investigational type of gene transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells are a type of white blood cell that fights infection and disease. Lymphoma is a type of cancer that affects the immune system, including B cells. The gene transfer involves drawing blood, separating out T cells (white blood cells that fight infection and disease), changing the T cells' DNA (genetic material) in a specific way, and returning the changed T cells back to the body. Researchers want to learn the highest dose of the changed T cells that can be given safely. Researchers also want to learn how long the changed T cells remain in the participant's body, and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.

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Interventions

LeukapheresisPROCEDURE
Leukapheresis #1 - For Collecting T Cells Leukapheresis #2 - For Collecting Stem Cells, month following #1 Blood drawn through vein, passed through a machine to collect specific blood cells, then remaining blood returned, about 3 hours to complete.
Stem Cell TransplantPROCEDURE
Stem cell infusion by vein over 30-45 minutes on Day 0
CD19-specific T Cell InfusionPROCEDURE
T Cell Infusion (Gene Transfer) by vein over 15-30 minutes sometime between Day +2 through Day +7.
IL-2DRUG
Group 2 or 4, IL-2 dose of 0.3 x 10\^6 U/m\^2 injected under skin, once a day for up to 14 days; first dose on day of T cell infusion.
CarmustineDRUG
300 mg/m\^2 IV over 1 hour on Day -6
EtoposideDRUG
200 mg/m\^2 IV over 3 hours every 12 hours on Days -5 to -2
CytarabineDRUG
200 mg/m\^2 by vein over 1 hour every 12 hours on Days -5 to -2.
MelphalanDRUG
140 mg/m\^2 IV over 30 minutes on Day -1

Study Locations

FacilityCityStateCountry
University of Texas MD Anderson Cancer CenterHoustonTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026