drugset / Trial / NCT04629833
Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-08-16
- Primary completion
- 2027-08
- Completion
- 2030-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | — |
| Comparator | Everolimus | Small molecule | — | — |
| Subject | MC0518 | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | MC0518 | Cell therapy | 2e+06 cells/kg | Intravenous |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |
| Comparator | Ruxolitinib | Small molecule | — | — |