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Brief Title: 4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3
Official Title: 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
Study ID: NCT03980288
Brief 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
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
First affiliated hospital, Zhejiang University, Hangzhou, Zhejiang, China
Name: Tingbo Liang
Affiliation: The First Affiliated Hospital, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR