Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05344664
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-04-25
First Post:
2022-04-19
Brief Title:
Novel GPC3 CAR-T Cell Therapy for Hepatocellular Carcinoma
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Safety and Efficacy of Novel GPC3 CAR-T Cells in the Treatment of Hepatocellular Carcinoma Exploratory Clinical Studies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
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:
This is a single-center single-arm open-label Phase I study to evaluate the safety and efficacy of GPC3-CAR-T cell immunotherapy in the treatment of hepatocellular carcinoma
Detailed Description:
This study is a single-center dose-escalation prospective exploratory study to evaluate the safety and efficacy of GPC3 CAR-T cells in subjects with hepatocellular carcinoma The study was divided into two phases dose escalation and dose expansion The total study duration is expected to be 2 years The total time for each subject to participate in the study is expected to be more than 1 year including the screening period non-myeloablative chemotherapy pretreatment cell infusion-observation period follow-up period and then enter the survival follow-up followed by telephone follow-up every 2 months Collect subject survival information
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