Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03980288
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2019-06-02
Brief Title:
4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 escalationcohort 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None