Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART133
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|ClinicalTrials.gov Identifier: NCT02541370|
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : December 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Pancreatic Cancer Brain Tumor Breast Cancer Ovarian Tumor Colorectal Cancer Acute Myeloid and Lymphoid Leukemias||Biological: anti-CD133-CAR vector-transduced T cells||Phase 1 Phase 2|
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Chimeric CD(Cluster of Differentiation)133 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
Experimental: anti-CD133 CAR T cells
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
Patients receive anti-CD133-CAR retroviral vector-transduced autologous-derived T cells on days 0, 1, 2 in the absence of disease progression or unacceptable toxicity.
Biological: anti-CD133-CAR vector-transduced T cells
genetically engineered lymphocyte therapy
Other Name: genetically engineered lymphocyte therapy
- Occurrence of study related adverse events [ Time Frame: Until week 24 ]defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical
- Anti-tumor responses to CART-133 cell infusions [ Time Frame: up to 24 weeks ]
- in vivo existence of CART133 [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541370
|Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital|
|Beijing, Beijing, China, 100853|