Treatment for steroid-refractory acute graft-versus-host disease using mesenchymal stromal cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the effectiveness of MC0518, a type of mesenchymal stromal cell therapy, against the best available therapy (BAT) for patients suffering from steroid-refractory acute graft-versus-host disease (SR-aGvHD). The primary goal is to assess the overall response rate at Day 28 and overall survival up to 24 months. Participants include adults and adolescents who have previously undergone allogeneic hematopoietic stem cell transplantation and have not responded to first-line treatments. The study is designed to provide insights into a potentially more effective treatment option for this challenging condition.

Why it matters

Who can join: the full rules

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).

Where it's running

• 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

Study contacts

• Study coordinator: Clinical Trial Information
• Email: ClinicalTrialInformation@medac.de
• Phone: +49 40103 8006-0

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.