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RECRUITING
NCT06248697
EARLY_PHASE1

Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors

Sponsor: Shanghai Cell Therapy Group Co.,Ltd

View on ClinicalTrials.gov

Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 and CTLA-4 nanobodies (αPD1/CTLA-4-MSLN-CAR T cells) in patients with solid tumors.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2023-01-01

Completion Date

2026-12-31

Last Updated

2024-02-08

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

αPD1/CTLA4-MSLN-CAR T cells

BZE2209 is prepared by non-viral vector technology consisting of autologous CD3+T cells expressing mesothelin-specific chimeric antigen receptor (CAR), PD1 nanoantibody and CTLA4 antibody with dimethyl sulfoxide as medium. It can be used for direct intravenous infusion. Autologous CD3+ T cells were transfected with plasmids expressing anti-mesothelin-specific CAR, anti-PD1 nanoantibody and anti-CTLA-4 antibody by electroporation in vitro. Mesothelin-specific CAR is a single-domain antibody (VHH) derived from alpaca, which is composed of a binding domain and a CD28 and CD3ζ chain signal transduction domain.

Locations (1)

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, China