GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

Launched by JIANMING XU · Apr 23, 2022

Keywords

ClinConnect Summary

This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of CART cell in patients ≥ 18 years of age with relapsed or refractory advanced hepatocellular carcinoma. Patients who meet the eligibility criteria will receive cell infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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;
• • 2. Age 18-75 years;
• • 3. Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy;
• • 4. GPC3 is detected positive by immunohistochemistry (IHC);
• • 5. Child-Pugh score ≤ 7;
• • 6. At least one assessable tumor lesion;
• • 7. ECOG score: 0-1;
• • 8. Expected survival ≥ 3 months;
• • 9. Clinical laboratory values meet screening visit criteria
• Exclusion Criteria:
• • 1. Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target;
• • 2. Any previous GPC3 targeted therapy;
• • 3. Prior antitumor therapy with insufficient washout period;
• • 4. Brain metastases with central nervous system symptoms;
• • 5. Pregnant or lactating women
• • 6. HCV-Ab or/and HIV-Ab positive; active syphilis;
• • 7. Severe underlying diseases
• • 8. Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.