GPC3-targeting LCAR-H93T Cell in Treatment of Advanced Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Oct 28, 2026
  • participants needed
    34
  • sponsor
    jianming xu
Updated on 28 June 2022

Summary

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

Details
Condition Advanced Hepatocellular Carcinoma
Treatment LCAR-H93T Cells
Clinical Study IdentifierNCT05352542
Sponsorjianming xu
Last Modified on28 June 2022

Eligibility

Yes No Not Sure

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
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