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
Objective
Primary Objective: To evaluate the efficacy of CYP-001 and CS vs placebo and CS in adults with HR-aGvHD based on Overall Response Rate (ORR) at Day 28.
Secondary Objectives: To assess additional responses and long-term efficacy outcomes. To assess Overall Survival (OS). To assess Event-Free survival (EFS). To assess Non-Relapse Mortality (NRM). To assess Failure Free Survival (FFS). To assess the incidence of Malignancy Relapse/Progression. To measure the incidence of chronic GvHD. To assess the cumulative steroid dose until Day 100. To evaluate changes in Subject Reported Outcomes.To evaluate the safety and tolerability of CYP-001 in subjects with aGvHD
