NCT05276076

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2022

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 2, 2022

Last Update Submit

March 2, 2022

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of VM-001 [ Time Frame: 1 week ]

    First 7-day treatment dose limiting toxicities (DLT) graded according to CTCAE in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels

    7 day cycle

Study Arms (5)

Part 1 Single Ascending Dose, Cohort 1

EXPERIMENTAL

Cohort 1 : 1X10\^6 cells/kg The safety of 2 subjects is evaluated for 1 week after single dose of IP. If CTCAE grade 3 or higher adverse drug events (ADR) do not occur in the two subjects: Begin enrollment for Cohort 2.

Biological: VM-001 1X10^6 cells/kg

Part 1 Single Ascending Dose, Cohort 2

EXPERIMENTAL

Cohort 2 : 3X10\^6 cells/kg The safety of 2 subjects is evaluated for 1 week after single dose of IP. If CTCAE grade 3 or higher adverse drug events (ADR) do not occur in the two subjects: Begin enrollment for Cohort 3.

Biological: VM-001 3X10^6 cells/kg

Part 1 Single Ascending Dose, Cohort 3

EXPERIMENTAL

Cohort 3 : 5X10\^6 cells/kg The safety of 2 subjects is evaluated for 1 week after single dose of IP.

Biological: VM-001 5X10^6 cells/kg

Part 2 Multiple Ascending Dose, Cohort 1

EXPERIMENTAL

Cohort 1 : two doses in total, 1X10\^6 cells/kg per dose, weekly The safety of 3 subjects is evaluated for 4 week after two dose of IP. If CTCAE grade 3 or higher adverse drug events (ADR) do not occur in the three subjects: Begin enrollment for Cohort 2.

Biological: VM-001 1X10^6 cells/kg two dose

Part 2 Multiple Ascending Dose, Cohort 2

EXPERIMENTAL

Cohort 2 : four doses in total, 1X10\^6 cells/kg per dose, weekly The safety of 3 subjects is evaluated for 8 week after two dose of IP.

Biological: VM-001 1X10^6 cells/kg four dose

Interventions

VM-001 1X10^6 cells/kgBIOLOGICAL

Administration: Inject intravenously single dose

Part 1 Single Ascending Dose, Cohort 1
VM-001 3X10^6 cells/kgBIOLOGICAL

Administration: Inject intravenously single dose

Part 1 Single Ascending Dose, Cohort 2
VM-001 5X10^6 cells/kgBIOLOGICAL

Administration: Inject intravenously single dose

Part 1 Single Ascending Dose, Cohort 3
VM-001 1X10^6 cells/kg two doseBIOLOGICAL

Administration: Inject intravenously 1X10\^6 cells/kg per dose, two dose in total, weekly

Part 2 Multiple Ascending Dose, Cohort 1
VM-001 1X10^6 cells/kg four doseBIOLOGICAL

Administration: Inject intravenously 1X10\^6 cells/kg per dose, four dose in total, weekly

Part 2 Multiple Ascending Dose, Cohort 2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥19 years of age
  • Acute GvHD or chronic GvHD after hematopoietic stem cell transplant
  • Subjects who no longer have available standard treatment.
  • ANC≥1,000cells./mm\^3
  • AST, ALT, total bilirubin less than 3 times the upper limit of normal
  • serum creatinine less than 1.5 times the upper limit of normal

You may not qualify if:

  • Received an anti-thymocyte globulin(ATG) within 14 days before enrollment
  • FCV or FEV less than 70%
  • Any uncontrolled infection or active infection requiring ongoing systemic treatment
  • Received an investigational agent within 6 months before enrollment.
  • Evidence of bleeding diathesis or coagulopathy.
  • Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • Breastfeeding or pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Chang-Ki Min, MD, Ph.D.

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyo Jung Park, Ph.D.

CONTACT

82-70-4348-7457parkhyojung@vigencell.com

Hyun-Jung Sohn, Ph.D.

CONTACT

82-70-4348-7527sohnhj@vigencell.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 11, 2022

Study Start

November 20, 2022

Primary Completion

November 20, 2024

Study Completion

November 20, 2025

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share