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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Graft Versus Host Disease, Acute

In brief

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.

Key facts

Study ID

NCT05643638

Run by

Cynata Therapeutics Limited

People needed

60

Starts

2024-03-04

Expected to finish

2027-12-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergone allogeneic hematopoietic stem cell transplant (HSCT)
• 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

You may not qualify if…

• Received any systemic treatment for aGvHD other than corticosteroids +/- calcineurin inhibitors
• 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.

Where it is running

• Royal Prince Alfred Hospital — Sydney, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• 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 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

Full record on ClinicalTrials.gov

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