Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-24
Brief Title:
CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia Prognostic Impact on Patients With Early CAR-T Cell Dysfunction
Sponsor:
Beijing GoBroad Hospital
Organization:
Beijing GoBroad Hospital
Study Overview
Official Title:
Cytokine-induced KillerCIK Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-TCAR-T Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia A Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 is a single-center double-blind randomized trial Patients with relapsed or refractory acute B-lymphoblastic leukemiarr B-ALL experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups the control cell group the CIK treatment group and the messenger RNAmRNA-CIK treatment group The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult AYA with rr B-ALL The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy groupA total number of 213 subjects will be enrolled
Detailed Description:
None
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