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Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease — BALDER  

Steroid-refractory Acute Graft-versus-host Disease Clinical Trial

Official title:
A Randomised, Open-label, Controlled, Multicentre, Phase 2 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Paediatric Participants With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation (BALDER Trial)

Clinical Trial Summary

The purpose of this trial is the comparative evaluation of overall response rate (ORR) in paediatric participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Visit Day 28 after treatment with MC0518 or first used best available therapy (BAT).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06075706
Study type Interventional
Source medac GmbH
Contact Medac Clinical Trial Information
Phone +49 (0)4103 8006
Email ClinicalTrialInformation@medac.de
Status Recruiting
Phase Phase 2
Start date November 13, 2023
Completion date June 2031
View Details
See also
  Status Clinical Trial Phase
Completed NCT03327857 - Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease Phase 1
Recruiting NCT04629833 - Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy Phase 3