Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04506983
Status:
SUSPENDED
Last Update Posted:
2022-02-14
First Post:
2020-08-06
Brief Title:
GPC3-CAR-T Cells for the Hepatocellular Carcinoma
Sponsor:
Beijing Tsinghua Chang Gung Hospital
Organization:
Beijing Tsinghua Chang Gung Hospital
Study Overview
Official Title:
The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients
Status:
SUSPENDED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adjust the plan
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 cells in patients with hepatocellular carcinoma
Detailed Description:
GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3 Patients with hepatocellular carcinoma will be enrolled and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1106 3106 10106 GPC3-CAR-T cells Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time day 0 day 4 day 7 day 10 day 14 day 28 The aim of this clinical trial is to evaluate the safety and efficacy of GPC3-CAR-T cells therapy in patients with hepatocellular carcinoma The primary endpoint is the safety of CAR-T cells including the effect ratio of CRS and ICANS ORR The secondary endpoint is the CAR-T ratio and CAR gene copied number in PB PFS OS and DOR
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