Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT03884751
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2019-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chimeric Antigen Receptor T Cells Targeting Glypican-3
Sponsor:
CARsgen Therapeutics Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Clinical Study of Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CAR-GPC3 T Cells) in Patients With Advanced Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-02
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 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-arm, multicenter clinical trial designed to observe and evaluate the safety, cell metabolokinetics, and efficacy of CAR-GPC3 T cells infused intravenously at single escalating doses in patients with 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 metabolic kinetics of single infusion of CAR-GPC3 T cells
* To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells
* To observe the 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 metabolic kinetics of single infusion of CAR-GPC3 T cells
* To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells
* To observe the efficacy of CAR-GPC3 T cells in the treatment of advanced hepatocellular carcinoma
Study Oversight
Has Oversight DMC:
True
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?: