Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726682
Status:
WITHDRAWN
Last Update Posted:
2024-03-05
First Post:
2023-02-02
Brief Title:
A Study to Investigate Use of Off-the-shelf Natural Killer NK Cells SAR445419 in Allogeneic Hematopoietic Stem Cell Transplantation HSCT
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 2 Single Arm Multicohort Open Label Multicenter Trial of Off-the-shelf Natural Killer NK Cells SAR445419 in Patients With High-risk Myeloid Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation HSCT
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to cancel trial not related to safety concern
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter parallel multicohort phase 2 single-arm study for adjunctive treatment in participants with high-risk myeloid malignancies undergoing allogeneic HSCT The purpose of this study is to assess the safety and preliminary efficacy of off-the-shelf OTS ex vivo expanded NK cells SAR445419 in improving relapse free survival RFS
Detailed Description:
The expected duration of the study for a participant is about 2 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1275-1345 | REGISTRY | ICTRP | None |