RecruitingPhase 1Phase 2NCT06590246

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


Sponsor

Shanghai AbelZeta Ltd.

Enrollment

121 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental CAR-T cell therapy called C-CAR031 for advanced liver cancer (hepatocellular carcinoma, or HCC) in patients whose tumors express a protein called GPC3. CAR-T therapy involves re-engineering a patient's own immune cells to attack cancer cells. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced liver cancer (HCC) with GPC3-positive tumors - Your cancer has progressed after at least 2 prior standard treatments - Your liver function is relatively preserved (Child-Pugh score of 6 or below) - You have at least one measurable tumor and your ECOG performance status is 0 or 1 - If you have Hepatitis B, it must be controlled with antiviral therapy **You may NOT be eligible if...** - You have previously received CAR-T therapy or any GPC3-targeted therapy - You have had a liver transplant or organ transplant - You have serious heart disease, epilepsy, recent stroke, or uncontrolled lung disease - You have HIV, active Hepatitis C, or active serious infections - You are pregnant or breastfeeding - Your tumor occupies more than 50% of your liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALArmored and GPC3-targeted autologous CAR T-cell

Armored and GPC3-targeted autologous CAR T-cells, single infusion intravenously.


Locations(2)

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06590246


Related Trials