A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
NCT ID: NCT05643638
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-03-04
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CYP-001 plus corticosteroids
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.
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.
Placebo plus corticosteroids
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Clinically diagnosed with acute GvHD requiring systemic therapy with corticosteroids.
* HR-aGvHD must meet one of the following clinical features within 72 hours prior to randomization: (a) high-risk as per Refined Minnesota Criteria; OR (b) One of the following: (i) isolated stage 2 involvement of the lower GI tract; (ii) Stage 1 lower GI tract disease with skin involvement
* Evidence of myeloid engraftment post allogeneic HSCT
* Life expectancy of at least one month
Exclusion Criteria
* Chronic GvHD or overlap syndrome with both acute and chronic features of GvHD
* Relapsed primary malignancy since
* received more than one allogeneic HSCT
* Clinically significant respiratory, renal or cardiac disease
* Cholestatic disorders or sinusoidal obstructive syndrome/veno-occlusive disease of the liver
* Any active uncontrolled infection requiring treatment and likely to impact on the ability of the subject to participate in the trial.
* Known infection with CMV, EBV, HHV-6, HBV, HCV, HIV or Tuberculosis. If the treatment for CMV, EBV, HHV-6, HBV, HCV has commenced the subject is eligible.
* Known sensitivity to dimethylsulfoxide (DMSO) or any other component of CYP-001.
* Received any investigational treatment agent within 30 days or within 5 half-lives of Screening, whichever is greater.
18 Years
ALL
No
Sponsors
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Cynata Therapeutics Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jolanta Airey, MD
Role: STUDY_DIRECTOR
Cynata Therapeutics Limited
Locations
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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)
Countries
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Central Contacts
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Other Identifiers
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CYP-GvHD-P2-01
Identifier Type: -
Identifier Source: org_study_id
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