NCT05344664

Novel GPC3 CAR-T Cell Therapy for Hepatocellular Carcinoma

Safety and Efficacy of Novel GPC3 CAR-T Cells in the Treatment of Hepatocellular Carcinoma Exploratory Clinical Studies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of GPC3-CAR-T cell immunotherapy in the treatment of hepatocellular carcinoma.

Detailed description

This study is a single-center, dose-escalation, prospective, exploratory study to evaluate the safety and efficacy of GPC3 CAR-T cells in subjects with hepatocellular carcinoma. The study was divided into two phases: dose escalation and dose expansion. The total study duration is expected to be 2 years. The total time for each subject to participate in the study is expected to be more than 1 year, including the screening period, non-myeloablative chemotherapy pretreatment, cell infusion-observation period, follow-up period, and then enter the survival follow-up, followed by telephone follow-up every 2 months, Collect subject survival information.

Interventions

Type	Name	Description
BIOLOGICAL	GPC3-CAR-T cells	The patients will receive one dose of GPC3-CAR-T.The dosage ranges from3×10\^6 to 1×10\^8 CAR-T+/kg.

Timeline

• Start date: 2022-04-14
• Primary completion: 2024-10-14
• Completion: 2025-02-01
• First posted: 2022-04-25
• Last updated: 2022-04-25