NCT07039201

A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)

An Exploratory Clinical Study on the Safety and Efficacy of Autologous Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CG-102-12C) in the Treament of Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate but uneffective systemic standard treatments.

Detailed description

This study is a single-centre, open-label, dose-escalation exploratory clinical trial. Its objective is to evaluate the safety, tolerability, recommended dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C infused in participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate systemic standard treatments. The study will be carried out in accordance with the protocol. Due to the early-stage of the exploratory clinical research,, the anticipated sample size for the three dose groups is 7-12 participants.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
BIOLOGICAL	CG-102-12C	Chimeric Antigen Receptor Autologous T-cell

Timeline

• Start date: 2025-06-28
• Primary completion: 2027-03-31
• Completion: 2027-07-31
• First posted: 2025-06-26
• Last updated: 2026-01-22

Locations

2 sites across 1 country: China