Immunotherapy using GPC3-targeted CAR-T cells for liver cancer
CAR-T Cell Targeting GPC3 for Immunotherapy of Hepatocellular Carcinoma: Phase I Clinical Trial
This study is testing a new treatment using specially modified immune cells to see if they can help people with advanced liver cancer that has a specific protein called GPC3.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | prednisone, CAR-T, CART, immunotherapy |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT03198546 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced hepatocellular carcinoma who express the GPC3 protein and have a life expectancy of more than 12 weeks.
Not a fit: Patients with severe viral infections, significant tumor burden, or those who have previously undergone gene therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with advanced liver cancer.
How similar studies have performed: Other studies have shown promise with CAR-T cell therapies targeting different antigens, suggesting potential success for this novel approach targeting GPC3.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.