Trials / Active Not Recruiting
Active Not RecruitingNCT06075706
Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- medac GmbH · Industry
- Sex
- All
- Age
- 28 Days – 17 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MC0518 | MC0518 will be intravenously infused immediately after thawing. |
| BIOLOGICAL | BAT | BAT including ECP, ATG, etanercept, infliximab or RUX will be administered based on Investigator's decision. |
Timeline
- Start date
- 2023-11-13
- Primary completion
- 2026-02-11
- Completion
- 2031-06-01
- First posted
- 2023-10-10
- Last updated
- 2026-04-14
Locations
36 sites across 5 countries: France, Germany, Italy, Poland, Spain
Source: ClinicalTrials.gov record NCT06075706. Inclusion in this directory is not an endorsement.