The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients

Date de début de l'étude : 10 juin 2022

Inclusion Criteria: 1. Age ≧18years, gender unlimited. 2. Failure or intolerance after at least first-line treatment. 3. GPC3 positive(IHC) 4. Patients must have at least one target lesion available for evaluation. 5. BCLC B or C. 6. Child-Pugh grade A or B 7. ECOG is 0 or 1 (one week before enrollment.) 8. Estimated life expectancy ≥ 3 months. 9. Functioning of major organs are normal. 10. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside. 11. Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures. Exclusion Criteria: 1. There are uncontrollable active infections that need systemic treatment. 2. HIV antibody is positive or syphilis antibody is positive. 3. Pregnant or lactating women. 4. hepatic encephalopathy. 5. patients with organ failure: * Heart: NYHA heart function grade IV; * Liver: Grade C that achieves Child-Turcotte liver function grading; * Kidney: kidney failure and uremia; * Lung: symptoms of respiratory failure; * Brain: a person with a disability. 6. It is undergoing systemic hormones therapy. 7. Impact results show that over 50% of the liver is occupied by tumor . 8. Patients who are still in the observation stage of other antitumor drugs 30 days before blood collection. 9. Patients were received other gene therapy products, or are participating in other clinical trials within 4 weeks prior to cell infusion. 10. Abnormal thyroid function ≧Level 3. 11. Active autoimmune diseases require systemic treatment during the first two years of screening. 12. Patients have mental illness or history of drug abuse. 13. Patients are participating in other clinical studies. 14. The researchers found that it was unsuitable for the recipients to be enrolled.