RecruitingPhase 1Phase 2NCT05652920

Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC

A Phase Ib/II, Open-Label, Multi-Center Study to Investigate the Safety, PK, and Efficacy of Ori-C101 in Advanced Hepatocellular Carcinoma (HCC) Patients (BEACON)


Sponsor

OriCell Therapeutics Co., Ltd.

Enrollment

105 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR T-cell therapy called Ori-C101 — made from a patient's own immune cells engineered to target a protein called GPC3 — in patients with liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed and has not responded to other treatments. **You may be eligible if...** - You have confirmed liver cancer (HCC) with GPC3 protein expression on tumor tissue - Your cancer is at an intermediate or advanced stage and cannot be surgically removed - You have tried at least one prior systemic therapy **You may NOT be eligible if...** - Your tumor does not express GPC3 - You have severe liver dysfunction (e.g., Child-Pugh C) - You have active serious infections or significant other organ problems 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

BIOLOGICALOri-C101

Hepatic arterial infusion


Locations(7)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Hunan Cancer Hospital

Changsha, Hunan, China

The first hospital of Jilin University

Changchun, Jilin, China

West China Hospital

Chengdu, Sichuan, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

Zhongshan Hospital Fudan University

Shanghai, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT05652920


Related Trials