drugset / Trial / NCT06075706
Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2023-11-13
- Primary completion
- 2026-02-11
- Completion
- 2031-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MC0518 | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | MC0518 | Cell therapy | 2e+06 cells/kg | Intravenous |
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | — |
| Comparator | Etanercept | Protein / enzyme biologic | — | — |
| Comparator | Infliximab | Monoclonal antibody | — | — |
| Comparator | Ruxolitinib | Small molecule | — | — |