MedTrace Logo

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)

NCT05276076 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-03-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ViGenCell Inc.

    lead INDUSTRY

Principal Investigators

  • Chang-Ki Min, MD, Ph.D. · The Catholic University of Korea

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-20
Primary Completion
2024-11-20
Completion
2025-11-20

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276076 on ClinicalTrials.gov