Overview
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting LCAR-H93T Cell in Treatment of Advanced Hepatocellular Carcinoma
Description
This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of LCAR-H93T in patients ≥ 18 years of age with relapsed or refractory advanced hepatocellular carcinoma. Patients who meet the eligibility criteria will receive LCAR-H93T infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up
Eligibility
Inclusion Criteria:
- Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
- Age 18-75 years;
- Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy;
- GPC3 is detected positive by immunohistochemistry (IHC);
- Child-Pugh score ≤ 7;
- At least one assessable tumor lesion;
- ECOG score: 0-1;
- Expected survival ≥ 3 months;
- Clinical laboratory values meet screening visit criteria
Exclusion Criteria:
- Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target;
- Any previous GPC3 targeted therapy;
- Prior antitumor therapy with insufficient washout period;
- Brain metastases with central nervous system symptoms;
- Pregnant or lactating women
- HCV-Ab or/and HIV-Ab positive; active syphilis;
- Severe underlying diseases
- Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.