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First received: November 29, 2022

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Graft Versus Host Disease, Acute

Study Type: INTERVENTIONAL


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 Treatm

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…

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