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New cell therapy aims to tame deadly transplant complication

NCT ID NCT05643638

Disease control Sponsor: Cynata Therapeutics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment called CYP-001 for people who develop a severe immune reaction (graft versus host disease) after a stem cell transplant. About 60 participants will receive either CYP-001 plus standard steroids or a placebo plus steroids. The goal is to see if adding CYP-001 improves the chance of controlling the disease without needing more treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft versus host disease, acute

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Anadolu Medical Center

    Eskişehir, Turkey (Türkiye)

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, Italy

  • BMT Group of Georgia

    Atlanta, Georgia, 30342, United States

  • Banner MD Anderson

    Phoenix, Arizona, 85012, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clínica Universidad de Navarra

    Pamplona, Spain

  • Dr Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Yenimahalle, Turkey (Türkiye)

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italy

  • Gayrettepe Florence Nightingale Hastanesi

    Istanbul, 34318, Turkey (Türkiye)

  • Hospital Claude Huriez

    Lille, France

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, Spain

  • Hospital Universitato De La Princesa

    Madrid, Spain

  • Hôpital Necker Enfants Malades

    Paris, France

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris, France

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, Spain

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Izmir Medicalpark Hospital

    Izmir, Turkey (Türkiye)

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Koc University

    Istanbul, Turkey (Türkiye)

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85288, United States

  • Mayo Clinic Hospital

    Jacksonville, Florida, 32224, United States

  • Memorial Bahcelievler Hospital

    Istanbul, Turkey (Türkiye)

  • Memorial healthcare System

    Pembroke Pines, Florida, 33026, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Ospedale dell'Angelo di Mestre

    Venezia, Italy

  • Penn State Health

    Hershey, Pennsylvania, 17033, United States

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029, Australia

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050, Australia

  • University Of Nebrasaka Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Arkansas Medical Center

    Little Rock, Arkansas, 72205, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, Lithuania

  • Weill Cornell Medicine - New York Presbyterian Hospital

    New York, New York, 10065, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • İnonu University

    Malatya, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.