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Clinical Study of Chimeric CD(Cluster of Differentiation)133 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD133 (cluster of differentiation antigen 133 ) vector (referred to as CART-133 cells). II. Determine duration of in vivo survival of CART-133 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-133 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time. SECONDARY OBJECTIVES: I. For patients with detectable disease, measure anti-tumor response due to CART-133 cell infusions. II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-133 TCR zeta:CD137 and TCR zeta cells over time. III. Estimate relative trafficking of CART-133 cells to tumor in bone marrow and lymph nodes. IV. For patients with stored or accessible tumor cells determine tumor cell killing by CART-133 cells in vitro. V. Determine if cellular or humoral host immunity develops against the murine anti-CD133, and assess correlation with loss of detectable CART-133 (loss of engraftment). VI. Determine the relative subsets of CART-133 T cells (Tcm, Tem, and Treg).
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Start Date
June 1, 2015
Primary Completion Date
June 1, 2019
Completion Date
June 1, 2019
Last Updated
December 17, 2019
20
ESTIMATED participants
anti-CD133-CAR vector-transduced T cells
BIOLOGICAL
Lead Sponsor
Chinese PLA General Hospital
NCT06345508
NCT04550494
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