Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-11 @ 9:07 PM
Study NCT ID:
NCT03146234
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR-GPC3 T Cells in Patients With Refractory Hepatocellular Carcinoma
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
Clinical Study of Redirected Autologous T Cells With a GPC3-targeted Chimeric Antigen Receptor in Patients With Refractory Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-11
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 study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there are no effective therapies known at this time.
Detailed Description:
A single arm, open-label pilot study is designed to determine the safety, tolerability and engraftment potential of CAR-GPC3 T cells in patients with GPC3-positive hepatocellular carcinoma.
Primary objectives:
Determine the safety, tolerability and cytokinetics of the autologous T cells transduced with the anti- GPC3 lentiviral vector in patients with hepatocellular carcinoma.
Secondary objectives:
Make a preliminary evaluation on the efficacy of CAR-GPC3 T cells in patients with hepatocellular carcinoma by the following parameters:
Objective response rate (ORR); Disease Control Rate (DCR); Time of tumor progression (TTP); Overall survival (OS).
Primary objectives:
Determine the safety, tolerability and cytokinetics of the autologous T cells transduced with the anti- GPC3 lentiviral vector in patients with hepatocellular carcinoma.
Secondary objectives:
Make a preliminary evaluation on the efficacy of CAR-GPC3 T cells in patients with hepatocellular carcinoma by the following parameters:
Objective response rate (ORR); Disease Control Rate (DCR); Time of tumor progression (TTP); Overall survival (OS).
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?: