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Leállítva1. fázis

GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

Megadott ok: achieve the proof of concept

Key facts

Where
Beijing, KínaSee the 2 sites
Phase
1. fázis

Where in Kína

  • Beijing Gobroad Boren HospitalBeijing, KínaNo longer taking part
  • Chinese PLA General HospitalBeijing, KínaNo longer taking part

Trial details

Who runs it
jianming xu
Trial code
NCT05352542
Record updated
2024. augusztus 9.
Original description
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular CarcinomaRead full original descriptionShow less

A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

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; 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; Brain metastases with central nervous system symptoms; Pregnant or lactating women.

ClinicalTrials.gov NCT05352542