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

Graft Versus Host Disease, Acute Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Disease
• Graft Versus Host Disease, Acute
• Graft vs Host Disease

• NCT number: NCT05643638
• Study type: Interventional
• Source: Cynata Therapeutics Limited
• Contact: Cynata Project Manager
• Phone: +61 3 7067 6940
• Email: clinical@cynata.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 4, 2024
• Completion date: December 31, 2026