NCT02541370

Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART133

Clinical Study of Chimeric CD(Cluster of Differentiation)133 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Liver Cancer
• Pancreatic Cancer
• Brain Tumor
• Breast Cancer
• Ovarian Tumor
• Colorectal Cancer
• Acute Myeloid and Lymphoid Leukemias

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD133-CAR vector-transduced T cells	genetically engineered lymphocyte therapy

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2015-09-04
• Last updated: 2019-12-17

Locations

1 site across 1 country: China