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Clinical Trials in Germany / NCT04629833
Recruiting Phase 3

Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy

NCT04629833 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Phase 3
Started
2021-08-16
Last updated
2025-08-13

Condition(s) studied

Steroid-refractory Acute Graft-versus-host Disease

Investigational drug(s) / intervention(s)

MC0518 →BAT

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.

Study summary

The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) at Day 28 and/or overall survival (OS) until Visit Month 24 in adult and adolescent subjects with steroid-refractory acute graft-versus-host disease (SR-aGvHD).

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 haematological malignant disease, irrespective of human leukocyte antigen match * 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 overt relapse or progression or persistence of the underlying disease at the Screening Visit * 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).

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud Amiens France Recruiting
CHU Jean Minjoz Besançon France Recruiting
Hopital Michallon Grenoble France Recruiting
CHRU Lille- Hopital Claude Huriez Lille France Recruiting
CHU de Nantes - Hotel Dieu Nantes France Recruiting
CHU de Nice Hopital Archet 1 Nice France Recruiting
Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G Pierre-Bénite France Recruiting
Centre Hospitalier Universitaire CHU de Toulouse Toulouse France Recruiting
Hopitaux De Brabois Vandœuvre-lès-Nancy France Recruiting
Klinikum rechts der Isar Munich Bavaria Recruiting
Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene Blutstammzelltransplantation Würzburg Bavaria Recruiting
Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main Frankfurt am Main Hesse Recruiting
Medizinische Hochschule Hannover Hanover Lower Saxony Recruiting
Uniklinik Koeln Cologne North Rhine-Westphalia Active Not Recruiting
Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT) Essen North Rhine-Westphalia Recruiting
Universitaetsklinikum Muenster Münster North Rhine-Westphalia Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden Dresden Saxony Recruiting
Universitaetsklinikum Leipzig, Selbststaendige Abteilung fur Haematologie und Internistische Onkologie Leipzig Saxony Recruiting
Universitaetsklinikum Jena Klinik fuer Innere Medizin II, Haematologie und Onkologie Jena Thuringia Recruiting
Universitaetsklinikum Jena - Klinik fuer Paediatrische Haematologie und Onkologie Jena Thuringia Terminated
Charite Universitaetsmedizin Berlin Germany Withdrawn
Helios Klinikum Berlin-Buch Berlin Germany Recruiting
University Hospital Bonn, Medizinische Klinik III Bonn Germany Recruiting
Universitaetsklinikum Essen - Klinik fuer Paediatrische Haematologie und Onkologie Essen Germany Terminated
Klinikum der Johann Wolfgang Goethe University - University - Klinik fuer Paediatrische Haematologie und Onkologie Frankfurt Germany Recruiting
Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie Freiburg im Breisgau Germany Terminated
Universitaetsklinikum Freiburg Freiburg im Breisgau Germany Recruiting
Universitatsklinikum Kiel Germany Recruiting
University Medical Center Mainz Mainz Germany Recruiting
Universitaetsklinikum Mannheim Mannheim Germany Recruiting
University Hospital Tuebingen Medical Center Tübingen Germany Recruiting
Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University Wroclaw Lower Silesian Voivodeship Terminated
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Paastwowy Instytut Badawczy Gliwice Poland Recruiting
Hospital Germans Trias i Pujol Badalona Spain Recruiting
Hospital Universitario Vall dHebron Barcelona Spain Recruiting
Institut Catal dOncologia Barcelona Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Hospital Puerta De Hierro Madrid Spain Recruiting
Hospital Universitario Carlos Haya Málaga Spain Recruiting
Hospital Clinico Universitario de Valencia Valencia Spain Recruiting

+ 2 more sites — see the full list on the official registry below.

More medac GmbH trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04629833 on ClinicalTrials.gov ↗ ← All trials in Germany