NCT04629833

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

A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Steroid-refractory Acute Graft-versus-host Disease

Interventions

Type	Name	Description
BIOLOGICAL	MC0518	MC0518 will be intravenously infused immediately after thawing.
BIOLOGICAL	BAT	BAT including MMF, ECP, ATG, everolimus, and RUX will be administered based on Investigator's decision.

Timeline

• Start date: 2021-08-16
• Primary completion: 2027-08-01
• Completion: 2030-08-01
• First posted: 2020-11-16
• Last updated: 2025-08-13

Locations

42 sites across 5 countries: France, Germany, Poland, Spain, Sweden