NCT03980288

4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	CAR-GPC3 T Cells	Pretreatment with fludarabine and cyclophosphamide CAR-GPC3 T Cells infusion

Timeline

• Start date: 2019-07-23
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2019-06-10
• Last updated: 2023-01-31

Locations

1 site across 1 country: China