Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 4:36 AM
Study NCT ID:
NCT03904069
Status:
WITHDRAWN
Last Update Posted:
2023-06-12
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 Chimeric Antigen Receptor T-cell (CAR-T) AMG 553 in Subjects With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia.
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Following a recent cellular therapy strategy assessment, Amgen has decided to cancel study 20180091.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the safety and tolerability of AMG 553 in adult and adolescent subjects with FLT3-positive R/R AML.
Determine the maximum tolerated cell dose (MTCD) or recommended phase 2 cell dose (RP2CD) of AMG 553.
Determine the maximum tolerated cell dose (MTCD) or recommended phase 2 cell dose (RP2CD) of AMG 553.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: