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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)

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
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05276076
Enrollment
12
Registered
2022-03-11
Start date
2022-11-20
Completion date
2025-11-20
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease

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.

Interventions

BIOLOGICALVM-001 1X10^6 cells/kg

Administration: Inject intravenously single dose

BIOLOGICALVM-001 3X10^6 cells/kg

Administration: Inject intravenously single dose

BIOLOGICALVM-001 5X10^6 cells/kg

Administration: Inject intravenously single dose

BIOLOGICALVM-001 1X10^6 cells/kg two dose

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

BIOLOGICALVM-001 1X10^6 cells/kg four dose

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

Sponsors

ViGenCell Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum Tolerated Dose (MTD) of VM-001 [ Time Frame: 1 week ]7 day cycleFirst 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

Contacts

Primary ContactHyo Jung Park, Ph.D.
parkhyojung@vigencell.com82-70-4348-7457
Backup ContactHyun-Jung Sohn, Ph.D.
sohnhj@vigencell.com82-70-4348-7527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026