Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03146234
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2017-04-24
Brief Title:
CAR-GPC3 T Cells in Patients With Refractory Hepatocellular Carcinoma
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
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:
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