Status:
TERMINATED
GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
Lead Sponsor:
jianming xu
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05352542
Start Date
May 19 2022
End Date
July 31 2024
Last Update
August 9 2024
Active Locations (2)
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1
Beijing Gobroad Boren Hospital
Beijing, Beijing Municipality, China
2
Chinese PLA General Hospital
Beijing, Beijing Municipality, China