Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05643638
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2022-11-29
Brief Title:
A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Sponsor:
Cynata Therapeutics Limited
Organization:
Cynata Therapeutics Limited
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination With Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease
Status:
RECRUITING
Status Verified Date:
2024-08
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 study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids CS to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium MAGIC guidelines Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days All subjects will receive ongoing CS therapy as appropriate per institutional guidelines Subjects will have study visits up to Day 100 during the Primary Evaluation Period During the Follow-Up Period subjects will have study visits up to 24 months
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