Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03605927
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2018-07-20
Brief Title:
CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2024-07
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:
The purpose of this study is to examine the safety and efficacy of the addition of BMS-986004 to standard of care Sirolimus SIR-based immune suppression
Detailed Description:
The approach builds upon extensive evidence supporting the benefit of CD40L blockade in disrupting key signaling events associated with immune activation The trial addresses a pressing clinical need namely prevention of Graft-Versus-Host Disease GVHD after hematopoietic cell transplantation HCT and promotion of donor-recipient immune tolerance The safety profile of this anti-CD40L antibody overcomes major prior limitations and the planned biologic studies will provide significant mechanistic insight
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