Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT07198867
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
Study Overview
Official Title:
A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2025-06
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 is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
Detailed Description:
The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow-up Visit
Study Oversight
Has Oversight DMC:
False
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?: