NCT06590246

A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)

Phase I/II Clinical Study of Armored and GPC3-targeted Autologous Chimeric Antigen Receptor (CAR) T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Recurrent Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 121 (estimated)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, open-label multicenter Phase I/II study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/recurrent HCC, who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments.

Detailed description

Part A (Phase I) is divided into two sections: dose escalation (Part A1) and dose expansion (Part A2). Part A1 will determine the recommended dose for expansion (RDE) to be used in Part A2 (dose expansion) of the study. Part A2 will further evaluate the safety, tolerability and efficacy of C-CAR031 to determine the recommended phase II dose (RP2D) to be used in Part B (Phase II).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Armored and GPC3-targeted autologous CAR T-cell	Armored and GPC3-targeted autologous CAR T-cells, single infusion intravenously.

Timeline

• Start date: 2024-09-30
• Primary completion: 2030-04-30
• Completion: 2043-04-30
• First posted: 2024-09-19
• Last updated: 2026-01-02

Locations

2 sites across 1 country: China