Immunotherapy using GPC3-targeted CAR-T cells for liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of GPC3-targeted CAR-T cells to treat patients with advanced hepatocellular carcinoma (HCC) that express the GPC3 protein. The study involves collecting and modifying patients' T cells to enhance their ability to target and kill cancer cells. Patients will undergo a biopsy to confirm GPC3 expression, followed by the infusion of genetically engineered T cells. The trial aims to assess the safety, tolerance, and preliminary efficacy of this innovative immunotherapy approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. patients with advanced HCC,which express GPC3 protein.
2. Life expectancy \>12 weeks
3. Child-Pugh-Turcotte score \<7
4. Adequate heart,lung,liver,kidney function
5. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3 CAR determined by flow-cytometry and killing of GPC3-positive targets greater than or equal to 20% in cytotoxicity assay
6. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Tumor size more than 25cm;
3. Severe virus infection such as HBV,HCV,HIV,et al
4. Known HIV positivity
5. History of liver transplantation
6. Active infectious disease related to bacteria, virus,fungi,et al
7. Other severe diseases that the investigators consider not appropriate;
8. Pregnant or lactating women
9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
10. Other conditions that the investigators consider not appropriate. -

Where it's running

• The First Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Zhenfeng Zhang, MD,PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD,PhD
• Email: zhangzhf@gzhmu.edu.cn
• Phone: 0086-020-34153532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.