NCT06560827

CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection

A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: CARsgen Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients with Hepatocellular Carcinoma at Risk of Recurrence after Surgical Resection.

Detailed description

This is a single-arm, open-label, multicenter, exploratory phase Ib clinical trial to evaluate the safety, efficacy, and cellular kinetics of CT011 CAR-GPC3 T cells (referred to as CT011) in participants with CNLC stage IIIa, GPC3-positive HCC at risk of recurrence after surgical resection.

Conditions

• HCC

Interventions

Type	Name	Description
BIOLOGICAL	CT011 CAR-GPC3 T Cells Injection	The dose selection for this trial was mainly based on the preliminary safety and efficacy results of CT011-HCC-01 trial in subjects with advanced HCC, in which 3 and 5 subjects in the 2.5 × 108 cell and 5.0 × 108 cell dose groups, respectively, completed a single infusion of CT011. The results showed that the two dose groups of CT011 were generally well tolerated in HCC subjects who failed to standard treatment, with controllable safety, and showed preliminary anti-tumor efficacy.

Timeline

• Start date: 2023-10-08
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2024-08-19
• Last updated: 2024-08-19

Locations

15 sites across 1 country: China