Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06018363
Status:
SUSPENDED
Last Update Posted:
2023-08-30
First Post:
2023-08-25
Brief Title:
Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection
Sponsor:
Dushu Lake Hospital Affiliated to Soochow University
Organization:
Dushu Lake Hospital Affiliated to Soochow University
Study Overview
Official Title:
Allogenic B7H3-targeting CAR-γδT Cell Therapy in rr GBM
Status:
SUSPENDED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial cannot be continued for the time being due to the renovation of the hospital premises
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study on the clinical application of chimeric antigen receptor modified γδ T cells CAR-γδ T cells in relapsed and refractory B7H3 Positive malignant brain gliomaThe main purpose of this study was to evaluate the safety and feasibility of CAR-γδ T cell infusion in patients with relapsed and refractory B7H3 Positive malignant brain glioma
Detailed Description:
γδT cells are known as a great candidate for car-t cells Although they only account for 2 - 5 of all T cells in our body they are a natural killer
Treatment on this study includes six B7H3 CAR-γδ Tcell infusions over an 12 week period B7H3 CAR-γδ T cells will be locoregionally administered via a CNS reservoir catheter without lymphodepleting chemotherapy The study will evaluate the safety feasibility and maximum tolerated dose MTD of B7H3 CAR-γδ T cell using a 33 study design and an 4 week evaluation period The total study duration will be 2 years
Treatment on this study includes six B7H3 CAR-γδ Tcell infusions over an 12 week period B7H3 CAR-γδ T cells will be locoregionally administered via a CNS reservoir catheter without lymphodepleting chemotherapy The study will evaluate the safety feasibility and maximum tolerated dose MTD of B7H3 CAR-γδ T cell using a 33 study design and an 4 week evaluation period The total study duration will be 2 years
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