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CTLA-4 and PD-1 Antibodies Expressing Mesothelin-CAR-T Cells for Mesothelin Positive Advanced Solid Tumor

Advanced Solid Tumor Clinical Trial

Official title:
A Clinical Study of CTL-A4 and PD-1 Antibodies Expressing Mesothelin-CAR-T Cells for Patients With Mesothelin Positive Advanced Solid Tumors

Clinical Trial Summary

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 express immune checkpoint antibodies (CTLA-4 and PD-1) and chimeric antigen receptor targeting mesothelin (mesoCAR-T) in adult patients with mesothelin positive, advanced recurrent or refractory malignant solid tumors.

Clinical Trial Description

This study will be conducted using a phase I/II trial design to assess the efficacy and safety of the CTLA-4 and PD-1 antibodies expressing mesothelin-CAR-T (mesoCAR-T) for patients with mesothelin positive, advanced recurrent or refractory malignant solid tumors. MesoCAR-T can specificly and effectively kill the mesothelin positive cancer cells, CTLA-4 and PD-1 antibodies 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 by leukapheresis, then activated and engineered to CTLA-4 and PD-1 antibodies expressing and chimeric antigen receptor targeting mesothelin. Cells are proliferated in culture and returned to the patients by venous transfusion. A total of 40 patients may be enrolled in the study. The total duration of the study is expected to be approximately 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03182803
Study type Interventional
Source Shanghai Cell Therapy Research Institute
Contact Zhiwei Zhang, Ph.D
Phone 0086-021-39595338
Email zhangzw@shcell.com
Status Recruiting
Phase Phase 1/Phase 2
Start date June 7, 2017
Completion date April 20, 2019
View Details
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