Clinical trialPhase 1 / Phase 2Unknown
PD-1 Antibody Expressing mesoCAR-T Cells for Mesothelin Positive Advanced Solid Tumor
A Clinical Study of PD-1 Antibody Expressing mesoCAR-T Cells for Patients With Mesothelin Positive Advanced Solid Tumors
- Outcome
- Outcome unknown
- Cell product
- CAR-T cells
Every cycle, peripheral blood mononuclear cells (PBMC) are collected on day -18, CAR-T cells are cultured in a GMP standard workshop.
- Target antigen
- mesothelin
PD-1 Antibody Expressing mesoCAR-T Cells for Mesothelin Positive Advanced Solid Tumor
- Cell source
- Autologous
This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to target mesothelin and express PD-1 antibodies in adult patients with advanced recurrent or
- Phase
- Phase 1 / Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- 6 August 2018
- Listed end
- 3 December 2020
- Enrollment
- 50 participants
- Sites
- 1
- Primary outcomes
- Incidence of treatment-related adverse events of infusion of autologous PD-1 antibody expressing mesothelin-targeted CAR-Tcells
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 3 August 2018
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to target mesothelin and express PD-1 antibodies in adult patients with advanced recurrent or refractory malignant solid tumors, which were positive expression of mesothelin.
Detailed description public domain (ClinicalTrials.gov)
This study will be conducted using a phase I/II trial design to assess the safety and efficacy of the PD-1 antibody expressing mesoCAR-T for patients with mesothelin positive, advanced recurrent or refractory malignant solid tumors. MesoCAR-T can specifically and effectively kill the mesothelin positive cancer cells, PD-1 antibody are secreted from the CAR-T cells could improve immunosuppression microenvironment, new CAR-T cells contain the advantages of CAR-T and immune checkpoint inhibitor, which is a promising therapeutic method for advanced solid tumors. The new CAR-T therapy is applied to clinical practice as bellow. T cells are prepared from peripheral blood mononuclear cells (PBMC) by leukapheresis, and then activated and engineered to express chimeric antigen receptors (CARs) targeting mesothelin and PD-1 antibody. Cells are proliferated in culture and returned to the patients by venous transfusion therapy. A total of 50 patients may be enrolled in the study. The total duration of the study is expected to be approximately 24 months.
Intervention public domain (ClinicalTrials.gov)
Biological: PD-1 antibody expressing mesoCAR-T cells. Patients with mesothelin positive cancer will be infused the PD-1 antibody expressing mesoCAR-T cells. The modified mesoCAR-T cells can specifically kill mesothelin positive cancer cells and secrete PD-1 antibody, which could enhance the cytotoxicity of mesoCAR-T cells and activate the tumor infiltrating lymphocytes.
Arm public domain (ClinicalTrials.gov)
PD-1 antibody expressing mesoCAR-T cells (experimental): Patients will receive two cycles of PD-1 antibody expressing mesoCAR-T cells treatment. Every cycle, peripheral blood mononuclear cells (PBMC) are collected on day -18, CAR-T cells are cultured in a GMP standard workshop. Patients are given a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes before cells infusion. Then the patients will receive an i.v.gtt infusion of PD-1 antibody expressing mesoCAR-T cells from day 1 to day 3 (±3days).