A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Status:
Not yet recruiting
Trial end date:
2026-03-31
Target enrollment:
Participant gender:
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.