NCT06248697

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-07-30
• Completion: 2026-12-31
• First posted: 2024-02-08
• Last updated: 2024-02-08

Locations

1 site across 1 country: China