Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03198052
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2017-06-22
Brief Title:
GPC3MesothelinClaudin182GUCY2CB7-H3PSCAPSMAMUC1TGFβHER2Lewis-YAXLEGFR-CAR-T Cells Against Cancers
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
CAR-T Targeting GPC3 Mesothelin Claudin182 GUCY2C B7-H3 PSCA PSMA MUC1 TGFβ HER2 Lewis-Y AXL or EGFR for Immunotherapy of Lung Cancer 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 third generation of CAR-T cells that target GPC3 Mesothelin Claudin182 GUCY2C B7-H3 PSCA PSMA MUC1 TGFβ HER2 Lewis-Y AXL or EGFR have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studiesClinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with GPC3 Mesothelin Claudin182 GUCY2C B7-H3 PSCA PSMA MUC1 TGFβ HER2 Lewis-Y AXL or EGFR expressions In this phase I study the safety tolerance and preliminary efficacy of the GPC3MesothelinClaudin182GUCY2CB7-H3PSCAPSMAMUC1TGFβHER2Lewis-YAXLEGFR
-CAR-T cell immunotherapy on human cancers will firstly be tested
-CAR-T cell immunotherapy on human cancers will firstly be tested
Detailed Description:
1 Choose appropriate patients with advanced lung or other cancerswith written consent for this study
2 Perform biopsy to determine the expression of HER2 Mesothelin Lewis-Y PSCA MUC1 GPC3 AXL EGFR Claudin182 or B7-H3 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 GPC3 Mesothelin Claudin182 GUCY2C B7-H3 PSCA PSMA MUC1 TGFβ HER2 Lewis-Y AXL or EGFR targeting CAR amplify the transfected T cells as needed test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections 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 GPC3MesothelinClaudin182GUCY2CB7-H3PSCAPSMAMUC1TGFβHER2Lewis-YAXLEGFR
-DAP10-CAR with knockdown of PD1HPK1
5 Other cancers with these cell surface antigen expressions are also recruited if needed
6 Evaluate the clinical results as needed
2 Perform biopsy to determine the expression of HER2 Mesothelin Lewis-Y PSCA MUC1 GPC3 AXL EGFR Claudin182 or B7-H3 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 GPC3 Mesothelin Claudin182 GUCY2C B7-H3 PSCA PSMA MUC1 TGFβ HER2 Lewis-Y AXL or EGFR targeting CAR amplify the transfected T cells as needed test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections 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 GPC3MesothelinClaudin182GUCY2CB7-H3PSCAPSMAMUC1TGFβHER2Lewis-YAXLEGFR
-DAP10-CAR with knockdown of PD1HPK1
5 Other cancers with these cell surface antigen expressions are also recruited if needed
6 Evaluate the clinical results as needed
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