B010-A Injection for Treating Patients With GPC3 Positive Advanced Hepatocellular Carcinoma

Advanced Hepatocellular Carcinoma Clinical Trial

Official title: A Phase 1 Open-label, Single Arm Study Targeting Glypican-3 (GPC3) Chimeric Antigen Receptor Modified T Cells (CAR-T) for Treatment of Advanced Hepatocellular Carcinoma

Status Active, not recruiting

Clinical Trial Summary

This is an Open-label, Single Arm study to observe the safety and tolerability of B010-A in the treatment of advanced hepatocellular carcinoma.

Clinical Trial Description

All subjects participating in this study will receive peripheral blood mononuclear cell collection to produce B010-A injection products after enrollment. Subjects may receive bridging anti-cancer therapy while waiting for the production of B010-A injection. All subjects need to undergo baseline assessment before receiving cell infusion. For all subjects, the baseline assessment includes weight, body surface area, vital signs, physical examination, ECOG score, laboratory examination, coagulation function, etiological examination, 12-lead ECG, echocardiogram, cytokine testing, Tumor marker detection and ICE score, etc. Each subject will receive lymphodepletion prior to B010-A infusion, and dose-limiting toxicity (DLT) assessment will be performed on D28 after the first infusion. ;

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

• NCT number: NCT05070156
• Study type: Interventional
• Source: Tongji University
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: October 29, 2021
• Completion date: September 30, 2024