NCT06394622

A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Fudan University · 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 CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I

Detailed description

This was a dose-expansion study, we plan to enroll 6 to 12 patients with CD70-positive advanced malignant solid tumors to CGC729 treatment. The intended enrollment for the evaluation of treatment efficacy and safety was planned to be 3 to 6 patients per tumor type. We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells	Biological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine.

Timeline

• Start date: 2024-04-11
• Primary completion: 2026-06-28
• Completion: 2026-06-28
• First posted: 2024-05-01
• Last updated: 2024-05-01

Locations

1 site across 1 country: China