drugset / Trial / NCT05276076
A Prospective, Open Label, Dose-escalation, SAD/MAD, Multicenter, 24weeks, Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamics of Investigational Product (VM-001) in Patients With Graft-versus-host Disease(GvHD)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The present study is multi center, phase I/IIa clinical trial to evaluate the safety and pharmacodynamics of investigational Product (VM-001) in patients with graft-versus-host disease(GvHD). A total of 12 subjects (Part 1 SAD\[3 cohort(2 subjects/cohort)\], Part 2 MAD\[2 cohort(3subjects/cohort)\]) are recruited.
Timeline
- Start
- 2022-11-20
- Primary completion
- 2024-11-20
- Completion
- 2025-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VM-001 | Cell therapy | 1 cells/kg | Intravenous |
| Subject | VM-001 | Cell therapy | 3 cells/kg | Intravenous |
| Subject | VM-001 | Cell therapy | 5 cells/kg | Intravenous |