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)

Graft Versus Host Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05276076
• Other study ID #: VM-201
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 20, 2022
• Est. completion date: November 20, 2025

Study information

• Verified date: March 2022
• Source: ViGenCell Inc.
• Contact: Hyo Jung Park, Ph.D.
• Phone: 82-70-4348-7457
• Email: parkhyojung[@]vigencell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: November 20, 2025
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Biological:
• VM-001 1X10^6 cells/kg
Administration: Inject intravenously single dose
• VM-001 3X10^6 cells/kg
Administration: Inject intravenously single dose
• VM-001 5X10^6 cells/kg
Administration: Inject intravenously single dose
• VM-001 1X10^6 cells/kg two dose
Administration: Inject intravenously 1X10^6 cells/kg per dose, two dose in total, weekly
• VM-001 1X10^6 cells/kg four dose
Administration: Inject intravenously 1X10^6 cells/kg per dose, four dose in total, weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ViGenCell Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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