NCT03146234

CAR-GPC3 T Cells in Patients With Refractory Hepatocellular Carcinoma

Clinical Study of Redirected Autologous T Cells With a GPC3-targeted Chimeric Antigen Receptor in Patients With Refractory Hepatocellular Carcinoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
GENETIC	CAR-GPC3 T cells	Self-controlled dose escalation will be applied to the first 3 - 6 subjects enrolled. Classical "3+3" dose escalation will be applied to subsequent subjects based on the self-controlled dose escalation study.

Timeline

• Start date: 2017-03-17
• Primary completion: 2018-10-18
• Completion: 2018-10-18
• First posted: 2017-05-09
• Last updated: 2019-08-28

Locations

1 site across 1 country: China