Hepatocellular Carcinoma Clinical Trial
Official title:
Clinical Study of Redirected Autologous T Cells With a GPC3-targeted Chimeric Antigen Receptor in Patients With Refractory Hepatocellular Carcinoma
This study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there are no effective therapies known at this time.
A single arm, open-label pilot study is designed to determine the safety, tolerability and
engraftment potential of CAR-GPC3 T cells in patients with GPC3-positive hepatocellular
carcinoma.
Primary objectives:
Determine the safety, tolerability and cytokinetics of the autologous T cells transduced with
the anti- GPC3 lentiviral vector in patients with hepatocellular carcinoma.
Secondary objectives:
Make a preliminary evaluation on the efficacy of CAR-GPC3 T cells in patients with
hepatocellular carcinoma by the following parameters:
Objective response rate (ORR); Disease Control Rate (DCR); Time of tumor progression (TTP);
Overall survival (OS).
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