MedTrace Logo

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

NCT04629833 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-08-13

No results posted yet for this 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).

Conditions

  • Steroid-refractory Acute Graft-versus-host Disease

Interventions

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.

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Ann-Kristin Möller · medac GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2027-08-31
Completion
2030-08-31

Countries

  • France
  • Germany
  • Poland
  • Spain
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04629833 on ClinicalTrials.gov