Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03198546
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2017-06-21
Brief Title:
GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
CAR-T Cell Targeting GPC3 for Immunotherapy of Hepatocellular Carcinoma Phase I Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The thirdfourth generation of CAR-T cells that target GPC3 GPC3-CART cell andor soluble TGFβ GPC3TGFβ-CART have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies Clinical studies will be performed to test the anti-cancer function by the GPC3TGFβ-CAR-T cells in human HCC patients with GPC3 expression In this phase I study the safety tolerance and preliminary efficacy of the GPC3TGFβ-CAR-T cell immunotherapy on human will firstly be tested
Detailed Description:
1 Choose appropriate patients with advanced hepatocellular carcinomawith written consent for this study
2 Perform biopsy to determine the expression of GPC3 of the tumor by western blotting or IHC
3 Collect blood from the patients and isolate mononuclear cells activate the T cells and transfect the T cells with GPC3TGFβ targeting CAR orand scfvcytokines-secreting amplify the number of transfected T cells as needed test the quality and killing activity of the GPC3TGFβ-CART cells and then transplant back the patients via systemic or local infusions via artery or intra-tumor and follow up closely to collect related results as needed
4 To enhance the killing capability CD4 T cells are genetically engineered to express TGFβ-CAR and secret IL7CCL19 andor SCFVs against PD1CTLA4Tigit CD8T cells are constructed to express GPC3-DAP10-CAR with knockdown of PD1HPK1
5 Evaluate the clinical results as needed
6 Will also perform the similar clinical trial on lung squamous carcinoma with the GPC3 expression
2 Perform biopsy to determine the expression of GPC3 of the tumor by western blotting or IHC
3 Collect blood from the patients and isolate mononuclear cells activate the T cells and transfect the T cells with GPC3TGFβ targeting CAR orand scfvcytokines-secreting amplify the number of transfected T cells as needed test the quality and killing activity of the GPC3TGFβ-CART cells and then transplant back the patients via systemic or local infusions via artery or intra-tumor and follow up closely to collect related results as needed
4 To enhance the killing capability CD4 T cells are genetically engineered to express TGFβ-CAR and secret IL7CCL19 andor SCFVs against PD1CTLA4Tigit CD8T cells are constructed to express GPC3-DAP10-CAR with knockdown of PD1HPK1
5 Evaluate the clinical results as needed
6 Will also perform the similar clinical trial on lung squamous carcinoma with the GPC3 expression
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