Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
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|ClinicalTrials.gov Identifier: NCT02580747|
Recruitment Status : Unknown
Verified October 2015 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : October 20, 2015
Last Update Posted : October 20, 2015
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|
|Malignant Mesothelioma Pancreatic Cancer Ovarian Tumor Triple Negative Breast Cancer Endometrial Cancer Other Mesothelin Positive Tumors||Biological: anti-meso-CAR vector transduced T cells||Phase 1|
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-meso vector (referred to as CART-meso cells).
II. Determine duration of in vivo survival of CART-meso cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-meso TCR (T-cell receptor) zeta:CD137 over time.
I. For patients with detectable disease, measure anti-tumor response due to CART-meso cell infusions.
II. Estimate relative trafficking of CART-meso cells to tumor in bone marrow and lymph nodes.
III. For patients with stored or accessible tumor cells determine tumor cell killing by CART-meso cells in vitro.
IV. Determine if cellular or humoral host immunity develops against the murine anti-meso, and assess correlation with loss of detectable CART-meso (loss of engraftment).
V. Determine the relative subsets of CART-meso 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 Mesothelin Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2018|
Experimental: anti-meso 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-meso-CAR retroviral vector-transduced autologous-derived T cells on days 0, 1, 2 in the absence of disease progression or unacceptable toxicity.
Biological: anti-meso-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-meso cell infusions [ Time Frame: up to 24 weeks ]
- In vivo existence of CART-meso [ 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): NCT02580747
|Contact: Weidong Han, Dr.||firstname.lastname@example.org|
|Contact: Yao Wang, Dr.||email@example.com|
|Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, Dr. 86-10-66937463 firstname.lastname@example.org|
|Contact: Yao Wang, Dr. 86-10-66937376 email@example.com|
|Sub-Investigator: Yao Wang, Dr.|