NCT06870279

A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC

A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects With Advanced Clear Cell Renal Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).

Detailed description

This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.

Conditions

• Advanced Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	CGC738	CAR-NKT Cells treatment

Timeline

• Start date: 2025-05-25
• Primary completion: 2026-08-01
• Completion: 2026-12-31
• First posted: 2025-03-11
• Last updated: 2025-04-24