NCT05276076View on ClinicalTrials.gov

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)

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 20, 2022

Primary Completion Date

November 20, 2024

Study Completion Date

November 20, 2025

Conditions
Graft Versus Host Disease
Interventions
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"

All Listed Sponsors
lead

ViGenCell Inc.

INDUSTRY

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) | Biotech Hunter | Biotech Hunter