Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779917
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-03-10
Brief Title:
MesothelinGPC3GUCY2C-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:
MesothelinGPC3GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic 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 second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions In this phase I study the safety tolerance and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated
Detailed Description:
1 Choose appropriate patients with advanced pancreatic cancer or other cancers with written consent for this study
2 Perform biopsy to determine the expression of Mesothelin of the tumors 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 Mesothelin 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 required
4 To enhance the killing capability cotreatment the patients with PD1PDL1CTLA4 antibodies may be applied
5 Evaluate the clinical results as needed
2 Perform biopsy to determine the expression of Mesothelin of the tumors 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 Mesothelin 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 required
4 To enhance the killing capability cotreatment the patients with PD1PDL1CTLA4 antibodies may be applied
5 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