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A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Sponsor: Cynata Therapeutics Limited
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-03-04
Completion Date
2027-12
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
CYP-001: Cymerus induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (MSCs)
Cymerus MSCs are derived from iPSCs using the proprietary Cymerus platform technology.
Placebo
The placebo product is identical to CYP-001, except that it contains no active agent
Corticosteroids
All enrolled subjects in this trial must receive corticosteroids at a minimum dose of oral prednisone 2 mg/kg/day (or methylprednisolone 1.6 mg/kg/day IV) as therapy for aGvHD for at least for 72 hours post enrollment.
Locations (39)
Banner MD Anderson
Phoenix, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
University of Arkansas Medical Center
Little Rock, Arkansas, United States
Mayo Clinic Hospital
Jacksonville, Florida, United States
Memorial healthcare System
Pembroke Pines, Florida, United States
BMT Group of Georgia
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University Of Nebrasaka Medical Center
Omaha, Nebraska, United States
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Penn State Health
Hershey, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Hospital Claude Huriez
Lille, France
Hôpital Necker Enfants Malades
Paris, France
Hôpital Universitaire Pitié-Salpêtrière
Paris, France
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Ospedale dell'Angelo di Mestre
Venezia, Italy
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitato De La Princesa
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Anadolu Medical Center
Eskişehir, Turkey (Türkiye)
Gayrettepe Florence Nightingale Hastanesi
Istanbul, Turkey (Türkiye)
Koc University
Istanbul, Turkey (Türkiye)
Memorial Bahcelievler Hospital
Istanbul, Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, Turkey (Türkiye)
İnonu University
Malatya, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Yenimahalle, Turkey (Türkiye)