Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
NCT ID: NCT06075706
Last Updated: 2026-01-27
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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ACTIVE_NOT_RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2023-11-13
2031-06-30
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
NONE
Study Groups
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MC0518
Participants will be treated with intravenous infusions of MC0518 at a dose of 1 to 2\*10\^6 cells per kilogram (cells/kg) (based on body weight at the Screening Visit). Infusions will be administered once a week for 4 weeks (Visit Day 1, 8, 15, and 22). Participants with partial response (PR) on Day 28 will have 2 additional MC0518 infusions administered on Day 29 and 36.
MC0518
MC0518 will be intravenously infused immediately after thawing.
Best Available Therapy (BAT)
Participants will receive one of the following systemic BATs based on the Investigator's decision: extracorporeal photopheresis (ECP), anti-thymocyte globulin (ATG), etanercept, infliximab or ruxolitinib (RUX).
BAT
BAT including ECP, ATG, etanercept, infliximab or RUX will be administered based on Investigator's decision.
Interventions
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MC0518
MC0518 will be intravenously infused immediately after thawing.
BAT
BAT including ECP, ATG, etanercept, infliximab or RUX will be administered based on Investigator's decision.
Eligibility Criteria
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Inclusion Criteria
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
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.
28 Days
17 Years
ALL
No
Sponsors
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medac GmbH
INDUSTRY
Responsible Party
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Locations
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CHU de Bordeaux - Hopital des Enfants
Bordeaux, , France
CHU Grenoble Alpes - Hopital Couple Enfant (HCE)
La Tronche, , France
Centre Hospitalier Universitaire de Lille CHU Lille - Hopital Jeanne de Flandre HJF
Lille, , France
Institut d'Hematologie et d'Oncologie Pediatrique (IHOPe)
Lyon, , France
CHU de Marseille-Hopital de la Timone
Marseille, , France
Centre Hospitalier Regional Universitaire (CHRU) Montpellier - hopital Arnaud de Villeneuve
Montpellier, , France
CHU de Nantes - Hopital Mere Enfant
Nantes, , France
Hopital Robert Debre
Paris, , France
CHU de Rouen - Hopital Charles Nicolle
Rouen, , France
CHRU de Strasbourg - Hopital de Hautepierre
Strasbourg, , France
CHRU Nancy, Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Uniklinik RWTH Aachen, Klinik fur Kinder- und Jugendmedizin
Aachen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Klinikum der Johann Wolfgang Goethe
Frankfurt, , Germany
Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ)
Freiburg im Breisgau, , Germany
Justus-Liebig-Universitaet Giessen
Giessen, , Germany
Medizinische Hochschule Hannover MHH
Hanover, , Germany
Department of Pediatrics, Jena University Hospital
Jena, , Germany
Universitaetsklinikum Leipzig - Abteilung fuer Paediatrische Onkologie, Haematologie und Haemostaseologie
Leipzig, , Germany
Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Paediatrische Haematologie und Onkologie
Münster, , Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Bologna, , Italy
Pediatric Clinic Onco Hematology San Gerardo Hospital
Monza, , Italy
U.O.C. Oncoematologia Pediatrica, Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Hematology and Cellular Therapy Ospedale Bambino Gesu
Rome, , Italy
A.O.U. Citta della Salute e della Scienza di Torino Ospedale Infantile Regina Margherita
Turin, , Italy
Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Dzieciecy Szpital Kliniczny im. A.Gebali w Lublinie
Lublin, , Poland
Szpital Kliniczny im. Karola Jonschera UM
Poznan, , Poland
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Vall dHebron
Barcelona, , Spain
Hospital Sant Joan de Deu Barcelona (HSJDB)
Barcelona, , Spain
Hospital Niño Jesus
Madrid, , Spain
Hospital Infantil Universitario La Paz
Madrid, , Spain
Instituto de Investigacion Biomedica de Malaga IBIMA - sede Hospital Regional Universitario de Malaga HRUM Hospital Carlos Haya
Málaga, , Spain
Instituto Murciano de Investigacion Biosanitaria (IMIB) Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitari I politecnic La Fe Jose
Valencia, , Spain
Countries
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Other Identifiers
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MC-MSC.2/aGvHD
Identifier Type: -
Identifier Source: org_study_id
2023-503952-28-00
Identifier Type: OTHER
Identifier Source: secondary_id
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