GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Jun 23, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment for patients with advanced liver cancer, specifically those whose tumors express a protein called GPC3. The treatment involves using specially modified immune cells, known as CAR-T cells, which are designed to target and attack cancer cells. This trial will evaluate how safe this new treatment is, how well it works, and how patients respond to it.

To be eligible for the trial, participants must have advanced liver cancer that shows GPC3, a life expectancy of more than 12 weeks, and good overall health, among other criteria. Patients will receive the treatment and will be closely monitored throughout the study. It’s important to note that this trial is currently recruiting participants of all genders, aged between 18 and 80. If someone is interested, they will need to provide informed consent, meaning they will be fully informed about the trial and agree to participate. This research aims to offer hope for more effective treatments for those battling this challenging disease.

Gender

ALL

Eligibility 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. -