NCT06404281

γδ T-PD-1 Ab Cells in the Treatment of Advanced Solid Tumors

Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Advanced Solid Tumors, a Phase I Clinical Trail

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Changzhou No.2 People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of advanced solid tumors.

Detailed description

This is a single-center, single-arm, phase I clinical trial to evaluate the safety and efficacy of γδ T-PD-1 Ab cells in patients with advanced solid tumors without standard treatment. A typical 3+3 dose-escalation design will be used to determine the optimal dose level of γδ T-PD-1 Ab cells based on the incidence of dose-limiting toxicity (DLT). The initial infusion dose level will start from 3×10\^7/kg to 3×10\^8/kg in every 2 weeks.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	γδ T-PD-1 Ab cells	Cells will be extracted from a healthy donor, followed by ex-vivo expansion, activation and genetic engineering. The ex-vivo expanded γδ T-PD-1 Ab cells will be adoptively transfused to tumor patients.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2024-05-08
• Last updated: 2024-08-22

Locations

1 site across 1 country: China