NCT07487402

Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurrent/Metastatic Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.

Detailed description

This is an open-label study. This study is indicated for unresectable recurrent/metastatic hepatocellular carcinoma.The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies. 1. Main research objectives: To evaluate the safety and tolerability of metabolically armed GPC3 CAR-T cells injection (Meta10-GPC3) in patients with unresectable recurrent/metastatic hepatocellular carcinoma. 2. Secondary research objectives: (1)To evaluate the efficacy of metabolically armed GPC3 CAR-T-cell therapy in unresectable recurrent/metastatic hepatocellular carcinoma. (2) To assess the in vivo pharmacokinetic (PK) profile, phenotype, and functional activity of infused GPC3 CAR-T cells.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Metabolically Armed GPC3 CAR-T cells	Each subject receive metabolically armed GPC3 CAR- T cells by intravenous infusion.

Timeline

• Start date: 2026-03-30
• Primary completion: 2028-12-15
• Completion: 2029-04-15
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: China