NCT07172178

γδ T-PD-1 Ab Cells in the Treatment of Malignant Meningioma

Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Malignant Meningioma, a Phase I Clinical Trail

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not 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 malignant meningioma.

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 malignant meningioma. 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 injection dose level will start from 1×10\^7 to 1×10\^8 in every 2 weeks.

Conditions

• Malignant Meningioma

Interventions

Type	Name	Description
BIOLOGICAL	γδ T-PD-1 Ab cells	Patients will receive 6 cycles of ex-vivo expanded γδ T-PD-1 Ab cells treatments,at two-weeks' intervals.γδ T-PD-1 Ab cells are injected through the Ommaya device in a typical 3+3 dose-escalation design(Dose escalation, 1×10\^7, 3×10\^7, 1×10\^8).

Timeline

• Start date: 2025-10-15
• Primary completion: 2028-10-01
• Completion: 2029-10-01
• First posted: 2025-09-15
• Last updated: 2025-09-15