Trials / Unknown
UnknownNCT02580747
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
Clinical Study of Chimeric Mesothelin Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies
- Status
- Unknown
- Phase
- Phase 1
- 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-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. SECONDARY OBJECTIVES: 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).
Conditions
- Malignant Mesothelioma
- Pancreatic Cancer
- Ovarian Tumor
- Triple Negative Breast Cancer
- Endometrial Cancer
- Other Mesothelin Positive Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | anti-meso-CAR vector transduced T cells | genetically engineered lymphocyte therapy |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-11-01
- Completion
- 2018-11-01
- First posted
- 2015-10-20
- Last updated
- 2015-10-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02580747. Inclusion in this directory is not an endorsement.