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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: ViGenCell Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	VM-001 1X10^6 cells/kg	Administration: Inject intravenously single dose
BIOLOGICAL	VM-001 3X10^6 cells/kg	Administration: Inject intravenously single dose
BIOLOGICAL	VM-001 5X10^6 cells/kg	Administration: Inject intravenously single dose
BIOLOGICAL	VM-001 1X10^6 cells/kg two dose	Administration: Inject intravenously 1X10\^6 cells/kg per dose, two dose in total, weekly
BIOLOGICAL	VM-001 1X10^6 cells/kg four dose	Administration: Inject intravenously 1X10\^6 cells/kg per dose, four dose in total, weekly

Timeline

• Start date: 2022-11-20
• Primary completion: 2024-11-20
• Completion: 2025-11-20
• First posted: 2022-03-11
• Last updated: 2022-03-11