A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT05643638
Trial Phases:	Phase II	Protocol IDs:	CYP-GvHD-P2-01 (primary) NCI-2023-07137
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Cynata Therapeutics Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT05643638

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.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523

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