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New cell therapy aims to tame deadly transplant complication in kids

NCT ID NCT06075706

Disease control Sponsor: medac GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 MC0518 (made from donor cells) in children who have severe graft-versus-host disease (GvHD) after a stem cell transplant and did not get better with steroids. GvHD happens when the donor's immune cells attack the child's body. The trial compares MC0518 to the best available standard treatments. About 49 children will take part to see if MC0518 can improve or resolve GvHD within 28 days.

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

49 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Jun 2031

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

28 days to 17 years

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: 1. Participant had a previous allogeneic HSCT as indicated for non-malignant (including inborn errors of metabolism, primary immunodeficiencies, haemoglobinopathies, and bone marrow failure syndromes) or hematological malignant disease or neuroblastoma. 2. Participant has been clinically diagnosed with Grade II to IV aGvHD according to Harris et al. A biopsy of the involved organs with aGvHD is encouraged but not required. 3. Participant has experienced failure of previous first-line aGvHD treatment (that is, SR-aGvHD), defined as: * aGvHD progression within 3 to 5 days of therapy onset with \>=2 milligram per kilogram per day (mg/kg/day) of prednisone equivalent or * failure to improve within 5 to 7 days of treatment initiation with \>=2 mg/kg/day of prednisone equivalent or * incomplete response after greater than (\>) 28 days of immunosuppressive treatment including at least 5 days with \>=2 mg/kg/day of prednisone equivalent. 4. Male or female participant who is \>=28 days and \<18 years of age and has a minimum body weight of 3.2 kilograms (kg) at the Screening Visit. 5. Participant has an estimated life expectancy of \>28 days. 6. Participant, if female and of childbearing potential, agrees to use a highly effective contraceptive measure starting at the Screening Visit and continuing throughout the entire trial period. 7. Participant, if a fertile male, agrees to sexual abstinence or to use a condom during sexual activity with their female partner of childbearing potential or pregnant partner. Additionally, if their partner is a woman of childbearing potential (WOCBP), then their partner must use an additional highly effective contraceptive method during sexual activity starting at the Screening Visit and continuing throughout the entire trial period. 8. A written informed consent of the participant's parent(s) / legal guardian(s) (and participant's assent, when applicable) has been obtained according to national regulations. Exclusion Criteria: 1. Participant has overt relapse or progression or persistence of the underlying disease. 2. Participant has received the last HSCT for a solid tumor disease other than neuroblastoma. 3. Participant has graft-versus-host disease overlap syndrome. 4. Participant has received systemic first-line treatment for aGvHD other than steroids and a prophylaxis with other than calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, anti-thymocyte globulin, mycophenolate mofetil, methotrexate, abatacept, or cyclophosphamide. Note: In vitro or in vivo graft manipulation to prevent graft-versus-host disease (example, T-cell depletion) during HSCT is permitted. Restart of initial prophylaxis with calcineurin inhibitors, mammalian target of rapamycin inhibitors, or mycophenolate mofetil after aGvHD onset is permitted. 5. Participant has received prior mesenchymal stromal cell (MSC) treatment, including MC0518/Obnitix®. 6. Participant has a known pregnancy (as confirmed by a positive pregnancy test result at the Screening Visit) and / or is breastfeeding. 7. Participant has a known hypersensitivity to MC0518 and / or its excipients (dimethyl sulfoxide, human serum albumin, isotonic sodium chloride solution). 8. Participant has a known hypersensitivity or any contraindication to the Investigator's choice BAT (extracorporeal photopheresis, anti thymocyte globulin, etanercept, infliximab, or ruxolitinib) and / or its excipients. For a list of excipients please refer to the respective Summary of Product Characteristics. 9. Participant has an underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant. 10. Participant has an uncontrolled infection (examples, sepsis or multi-organ failure) including significant bacterial, fungal, viral, or parasitic infection requiring treatment. 11. Participant has received treatment with any other investigational agent within 30 days or 5 half-lives (whichever is longer) before the Screening Visit.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease

As listed by the trial registrant

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

Steroid-refractory acute graft versus host disease

Contacts and locations

Locations

  • A.O.U. Citta della Salute e della Scienza di Torino Ospedale Infantile Regina Margherita

    Turin, 10126, Italy

  • CHRU Nancy, Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • CHRU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67000, France

  • CHU Grenoble Alpes - Hopital Couple Enfant (HCE)

    La Tronche, 38700, France

  • CHU de Bordeaux - Hopital des Enfants

    Bordeaux, 33000, France

  • CHU de Marseille-Hopital de la Timone

    Marseille, 13385, France

  • CHU de Nantes - Hopital Mere Enfant

    Nantes, 44093, France

  • CHU de Rouen - Hopital Charles Nicolle

    Rouen, 73038, France

  • Centre Hospitalier Regional Universitaire (CHRU) Montpellier - hopital Arnaud de Villeneuve

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire de Lille CHU Lille - Hopital Jeanne de Flandre HJF

    Lille, 59037, France

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

  • Department of Pediatrics, Jena University Hospital

    Jena, 7747, Germany

  • Dzieciecy Szpital Kliniczny im. A.Gebali w Lublinie

    Lublin, 20-093, Poland

  • Hematology and Cellular Therapy Ospedale Bambino Gesu

    Rome, 165, Italy

  • Hopital Robert Debre

    Paris, 75019, France

  • Hospital Infantil Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Niño Jesus

    Madrid, Madrid, 28009, Spain

  • Hospital Sant Joan de Deu Barcelona (HSJDB)

    Barcelona, 8950, Spain

  • Hospital Universitari I politecnic La Fe Jose

    Valencia, 46026, Spain

  • Hospital Universitario Vall dHebron

    Barcelona, 8035, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi

    Bologna, 40138, Italy

  • Institut d'Hematologie et d'Oncologie Pediatrique (IHOPe)

    Lyon, 69373, France

  • Instituto Murciano de Investigacion Biosanitaria (IMIB) Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Instituto de Investigacion Biomedica de Malaga IBIMA - sede Hospital Regional Universitario de Malaga HRUM Hospital Carlos Haya

    Málaga, 29011, Spain

  • Justus-Liebig-Universitaet Giessen

    Giessen, 35392, Germany

  • Klinikum der Johann Wolfgang Goethe

    Frankfurt, 60596, Germany

  • Medizinische Hochschule Hannover MHH

    Hanover, 30625, Germany

  • Pediatric Clinic Onco Hematology San Gerardo Hospital

    Monza, 20052, Italy

  • Szpital Kliniczny im. Karola Jonschera UM

    Poznan, 60-572, Poland

  • U.O.C. Oncoematologia Pediatrica, Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Uniklinik RWTH Aachen, Klinik fur Kinder- und Jugendmedizin

    Aachen, 52074, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ)

    Freiburg im Breisgau, 79106, Germany

  • Universitaetsklinikum Leipzig - Abteilung fuer Paediatrische Onkologie, Haematologie und Haemostaseologie

    Leipzig, 4103, Germany

  • Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Paediatrische Haematologie und Onkologie

    Münster, 48129, Germany

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