Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
NCT ID: NCT04629833
Last Updated: 2025-08-13
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
PHASE3
210 participants
INTERVENTIONAL
2021-08-16
2030-08-31
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
NONE
Study Groups
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MC0518
Participants will receive MC0518 1-2 million cells/ kilogram infusions (based on body weight at the Screening Visit) 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 any one of the following systemic BATs based on the Investigator's decision: mycophenolate mofetil (MMF), extracorporeal photopheresis (ECP), anti-thymocyte globulin (ATG), everolimus, and ruxolitinib (RUX).
BAT
BAT including MMF, ECP, ATG, everolimus, and 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 MMF, ECP, ATG, everolimus, and RUX will be administered based on Investigator's decision.
Eligibility Criteria
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Inclusion Criteria
* Participant has been clinically diagnosed with Grade II to IV aGvHD at the Screening Visit
* Participant has experienced failure of previous first-line aGvHD treatment (ie, SR-aGvHD), defined as: a) aGvHD progression within 3 to 5 days of therapy onset with \>= 2 mg/kg/day of prednisone equivalent or b) failure to improve within 5 to 7 days of treatment initiation with \>= 2 mg/kg/day of prednisone equivalent or c) incomplete response after \> 28 days of immunosuppressive treatment including at least 5 days with \>= 2 mg/kg/day of prednisone equivalent
* Participant has an estimated life expectancy \> 28 days at the Screening Visit
* Male or female participant who is \>= 12 years of age at the Screening Visit
Exclusion Criteria
* Participant has received the last HSCT for a solid tumour disease
* Participant has GvHD overlap syndrome at the Screening Visit
* 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 (ATG), mycophenolate mofetil (MMF), methotrexate (MTX), and / or cyclophosphamide before the Screening Visit
* Participant has a known pregnancy (as confirmed by a positive pregnancy test at the Screening Visit) and or is breastfeeding at the Screening Visit
* Participant has received treatment with any other investigational agent within 30 days or 5 half-lives (whichever is longer) before the Screening Visit (compliance to be confirmed for the period between the Screening Visit and the Baseline Visit at the Baseline Visit).
12 Years
ALL
No
Sponsors
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medac GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Ann-Kristin Möller
Role: STUDY_DIRECTOR
medac GmbH
Locations
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Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
Amiens, , France
CHU Jean Minjoz
Besançon, , France
Hopital Michallon
Grenoble, , France
CHRU Lille- Hopital Claude Huriez
Lille, , France
CHU de Nantes - Hotel Dieu
Nantes, , France
CHU de Nice Hopital Archet 1
Nice, , France
Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G
Pierre-Bénite, , France
Centre Hospitalier Universitaire CHU de Toulouse
Toulouse, , France
Hopitaux De Brabois
Vandœuvre-lès-Nancy, , France
Klinikum rechts der Isar
Munich, Bavaria, Germany
Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene Blutstammzelltransplantation
Würzburg, Bavaria, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Uniklinik Koeln
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT)
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Universitaetsklinikum Leipzig, Selbststaendige Abteilung fur Haematologie und Internistische Onkologie
Leipzig, Saxony, Germany
Universitaetsklinikum Jena Klinik fuer Innere Medizin II, Haematologie und Onkologie
Jena, Thuringia, Germany
Universitaetsklinikum Jena - Klinik fuer Paediatrische Haematologie und Onkologie
Jena, Thuringia, Germany
Charite Universitaetsmedizin
Berlin, , Germany
Helios Klinikum Berlin-Buch
Berlin, , Germany
University Hospital Bonn, Medizinische Klinik III
Bonn, , Germany
Universitaetsklinikum Essen - Klinik fuer Paediatrische Haematologie und Onkologie
Essen, , Germany
Klinikum der Johann Wolfgang Goethe University - University - Klinik fuer Paediatrische Haematologie und Onkologie
Frankfurt, , Germany
Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie
Freiburg im Breisgau, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitatsklinikum
Kiel, , Germany
University Medical Center Mainz
Mainz, , Germany
Universitaetsklinikum Mannheim
Mannheim, , Germany
University Hospital Tuebingen Medical Center
Tübingen, , Germany
Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Paastwowy Instytut Badawczy
Gliwice, , Poland
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario Vall dHebron
Barcelona, , Spain
Institut Catal dOncologia
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Puerta De Hierro
Madrid, , Spain
Hospital Universitario Carlos Haya
Málaga, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i politecnic La Fe
Valencia, , Spain
Center for Allogeneic Stem Cell Transplantation and Cell Therapy (CAST), Karolinska Universitetssjukhuset Huddinge
Huddinge, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MC-MSC.1/aGvHD
Identifier Type: -
Identifier Source: org_study_id
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