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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)

Primary Purpose

Graft Versus Host Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
VM-001 1X10^6 cells/kg
VM-001 3X10^6 cells/kg
VM-001 5X10^6 cells/kg
VM-001 1X10^6 cells/kg two dose
VM-001 1X10^6 cells/kg four dose
Sponsored by
ViGenCell Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part 1 Single Ascending Dose, Cohort 1

    Part 1 Single Ascending Dose, Cohort 2

    Part 1 Single Ascending Dose, Cohort 3

    Part 2 Multiple Ascending Dose, Cohort 1

    Part 2 Multiple Ascending Dose, Cohort 2

    Arm Description

    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.

    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.

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

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2022
    Last Updated
    March 2, 2022
    Sponsor
    ViGenCell Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05276076
    Brief 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)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 20, 2022 (Anticipated)
    Primary Completion Date
    November 20, 2024 (Anticipated)
    Study Completion Date
    November 20, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ViGenCell Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graft Versus Host Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1 Single Ascending Dose, Cohort 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Part 1 Single Ascending Dose, Cohort 2
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Part 1 Single Ascending Dose, Cohort 3
    Arm Type
    Experimental
    Arm Description
    Cohort 3 : 5X10^6 cells/kg The safety of 2 subjects is evaluated for 1 week after single dose of IP.
    Arm Title
    Part 2 Multiple Ascending Dose, Cohort 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Part 2 Multiple Ascending Dose, Cohort 2
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    VM-001 1X10^6 cells/kg
    Intervention Description
    Administration: Inject intravenously single dose
    Intervention Type
    Biological
    Intervention Name(s)
    VM-001 3X10^6 cells/kg
    Intervention Description
    Administration: Inject intravenously single dose
    Intervention Type
    Biological
    Intervention Name(s)
    VM-001 5X10^6 cells/kg
    Intervention Description
    Administration: Inject intravenously single dose
    Intervention Type
    Biological
    Intervention Name(s)
    VM-001 1X10^6 cells/kg two dose
    Intervention Description
    Administration: Inject intravenously 1X10^6 cells/kg per dose, two dose in total, weekly
    Intervention Type
    Biological
    Intervention Name(s)
    VM-001 1X10^6 cells/kg four dose
    Intervention Description
    Administration: Inject intravenously 1X10^6 cells/kg per dose, four dose in total, weekly
    Primary Outcome Measure Information:
    Title
    Maximum Tolerated Dose (MTD) of VM-001 [ Time Frame: 1 week ]
    Description
    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
    Time Frame
    7 day cycle

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyo Jung Park, Ph.D.
    Phone
    82-70-4348-7457
    Email
    parkhyojung@vigencell.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyun-Jung Sohn, Ph.D.
    Phone
    82-70-4348-7527
    Email
    sohnhj@vigencell.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chang-Ki Min, MD, Ph.D.
    Organizational Affiliation
    The Catholic University of Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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)

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