Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05410717
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2022-06-05
Brief Title:
CLDN6GPC3MesothelinAXL-CAR-NK Cell Therapy for Advanced Solid Tumors
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Phase I Trial to Evaluate Safety and Preliminary Efficacy of CLDN6GPC3MesothelinAXL-CAR-NK in Patients With CLDN6GPC3MesothelinAXL-positive Advanced Solid Tumors
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:
This study is an open exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6 GPC3 Mesothelin or AXL targeting CAR-NK cells in patients with Claudin6 GPC3 Mesothelin or AXL-positive advanced solid tumors ovarian cancer and others
Detailed Description:
1 Choose appropriate advanced cancer patients with Claudin6 GPC3 Mesothelin or AXL expression with written consent for the study
2 Perform PBMCs apheresis from the patient and isolate NK cells transfect the NK cells with Claudin6 GPC3 Mesothelin or AXL targeting CAR amplify the number of transfected NK cells as needed test the quality and killing activity of the Claudin6 GPC3 Mesothelin or AXL-CAR-NK 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
3 To enhance the killing capability some CAR-NK cells are genetically engineered to express and secret IL7CCL19 andor SCFVs against PD1CTLA4Lag3 some CAR-NK cells are combined with CannabidiolCBD or Nicotinamide adenine dinucleotide NAD
4 Evaluate the clinical results as needed
5 Will also perform the similar clinical trial on different cancer types with Claudin6 GPC3 Mesothelin or AXL expression
2 Perform PBMCs apheresis from the patient and isolate NK cells transfect the NK cells with Claudin6 GPC3 Mesothelin or AXL targeting CAR amplify the number of transfected NK cells as needed test the quality and killing activity of the Claudin6 GPC3 Mesothelin or AXL-CAR-NK 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
3 To enhance the killing capability some CAR-NK cells are genetically engineered to express and secret IL7CCL19 andor SCFVs against PD1CTLA4Lag3 some CAR-NK cells are combined with CannabidiolCBD or Nicotinamide adenine dinucleotide NAD
4 Evaluate the clinical results as needed
5 Will also perform the similar clinical trial on different cancer types with Claudin6 GPC3 Mesothelin or AXL 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