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)
NCT ID: NCT05276076
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2022-11-20
2025-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1 Single Ascending Dose, Cohort 1
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.
VM-001 1X10^6 cells/kg
Administration: Inject intravenously single dose
Part 1 Single Ascending Dose, 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.
VM-001 3X10^6 cells/kg
Administration: Inject intravenously single dose
Part 1 Single Ascending Dose, Cohort 3
Cohort 3 : 5X10\^6 cells/kg The safety of 2 subjects is evaluated for 1 week after single dose of IP.
VM-001 5X10^6 cells/kg
Administration: Inject intravenously single dose
Part 2 Multiple Ascending Dose, Cohort 1
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.
VM-001 1X10^6 cells/kg two dose
Administration: Inject intravenously
1X10\^6 cells/kg per dose, two dose in total, weekly
Part 2 Multiple Ascending Dose, 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.
VM-001 1X10^6 cells/kg four dose
Administration: Inject intravenously
1X10\^6 cells/kg per dose, four dose in total, weekly
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
ALL
No
Sponsors
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ViGenCell Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chang-Ki Min, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Central Contacts
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Other Identifiers
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VM-201
Identifier Type: -
Identifier Source: org_study_id
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