Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03904069
Status:
WITHDRAWN
Last Update Posted:
2023-06-12
First Post:
2019-03-21
Brief Title:
Study Evaluating the Safety Tolerability and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive RelapsedRefractory AML
Sponsor:
Amgen
Organization:
Amgen
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 RelapsedRefractory 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WITHDRAWN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 RR 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:
None
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?:
None