NCT05373147

αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors

An Exploratory Study of αPD1-MSLN-CAR T Cells Secreting PD-1 Nanobodies for the Treatment of MSLN-positive Advanced Solid Tumors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Shanghai Mengchao Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 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 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.

Detailed description

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 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.The safety and efficacy of αPD1-MSLN-CAR T cells will be assessed in a standard 3+3 dose escalation approach. Four doses of CAR T cells will be evaluated in this study: 1×10\^5 CAR+ T cells/kg, 3×10\^5 CAR+ T cells/kg, 1×10\^6 CAR+ T cells/kg, and 3×10\^6 CAR+ T cells/kg.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	αPD1-MSLN-CAR T cells	The safety and efficacy of αPD1-MSLN-CAR T cells will be assessed in a standard 3+3 dose escalation approach. Four doses of CAR T cells will be evaluated in this study: 1×10\^5 CAR+ T cells/kg, 3×10\^5 CAR+ T cells/kg, 1×10\^6 CAR+ T cells/kg, and 3×10\^6 CAR+ T cells/kg.

Timeline

• Start date: 2020-10-30
• Primary completion: 2023-02-01
• Completion: 2023-08-01
• First posted: 2022-05-13
• Last updated: 2022-10-26

Locations

1 site across 1 country: China