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Clinical Trial Summary

A Phase I Clinical Study of 4th generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 ( CAR-GPC3 T Cells) in Patients with Advanced Hepatocellular Carcinoma


Clinical Trial Description

This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of CAR-GPC3 T cells, infused intravenously in subjects who have been diagnosed with GPC3 positive advanced hepatocellular carcinoma and refractory or intolerant to current standard systemic treatment. Primary objectives: •To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at escalating doses in patients with advanced hepatocellular carcinoma. Secondary objectives: - To evaluate the cellular pharmacokinetics of CAR-GPC3 T cells - To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells - To investigate the preliminary efficacy of CAR-GPC3 T cells in the treatment of advanced hepatocellular carcinoma ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03980288
Study type Interventional
Source Zhejiang University
Contact
Status Completed
Phase Phase 1
Start date July 23, 2019
Completion date December 30, 2020

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