RecruitingPhase 1NCT06560827

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


Sponsor

CARsgen Therapeutics Co., Ltd.

Enrollment

30 participants

Start Date

Oct 8, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized CAR-T cell therapy — where immune cells taken from your own body are genetically engineered to fight liver cancer — in patients who have had surgery for liver cancer and show signs that the cancer may be coming back. **You may be eligible if...** - You are aged 18–75 with liver cancer that was surgically removed - Your tumor tested positive for a protein called GPC3 - After surgery, your AFP blood marker (a cancer indicator) has been rising, suggesting the cancer may return - Your cancer had blood vessel involvement but no spread outside the liver - Your liver and general health are in reasonably good condition **You may NOT be eligible if...** - Your cancer has already come back or spread - It has been more than 2 years since your surgery - You have HIV, active hepatitis B or C, or active infections - You have had a prior organ transplant or received CAR-T therapy before - You are pregnant or breastfeeding 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.

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Interventions

BIOLOGICALCT011 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.


Locations(15)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Hunan Provincial People's Hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital of Sichuan University

Chengdu, China

Chongqing university ca cer hospital

Chongqing, China

Mengchao hepatobiliary hospital of fujian medical university

Fuzhou, China

Sun Yat-sen University Cancer Center

Guanzhou, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

The second affiliated hospital zhejiang university school of medicine

Hangzhou, China

Zhongshan Hospital Fudan University

Shanghai, China

Liaoning Cancer Hospital

Shenyang, China

The first hospital of china medical university

Shenyang, China

Tianjin medical university cancer hospital

Tianjin, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06560827


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