Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642025
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Single-arm Clinical Study of EX02 CAR-T Therapy for Relapsed and Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a early Phase 1 open-label single-arm clinical study of EX02 CAR-T therapy for relapsed and refractory acute myeloid leukemia
Each participant will undergo leukapheresis after enrolment receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine and an an intravenous infusion of CAR-T cells
Each participant will proceed through the following study procedures
Screening
EnrollmentLeukapheresis
Conditioning chemotherapy
CAR T treatment
Post-treatment assessment
Long-term follow-up
Each participant will undergo leukapheresis after enrolment receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine and an an intravenous infusion of CAR-T cells
Each participant will proceed through the following study procedures
Screening
EnrollmentLeukapheresis
Conditioning chemotherapy
CAR T treatment
Post-treatment assessment
Long-term follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None