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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Part 2 Multiple Ascending Dose, Cohort 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VM-001 1X10^6 cells/kg | Biological | Administration: Inject intravenously single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo Jung Park, Ph.D. | Contact | 82-70-4348-7457 | parkhyojung@vigencell.com | |
| Hyun-Jung Sohn, Ph.D. | Contact | 82-70-4348-7527 | sohnhj@vigencell.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang-Ki Min, MD, Ph.D. | The Catholic University of Korea | Principal Investigator |
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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. |
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| VM-001 3X10^6 cells/kg | Biological | Administration: Inject intravenously single dose |
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| VM-001 5X10^6 cells/kg | Biological | Administration: Inject intravenously single dose |
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| VM-001 1X10^6 cells/kg two dose | Biological | Administration: Inject intravenously 1X10^6 cells/kg per dose, two dose in total, weekly |
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| VM-001 1X10^6 cells/kg four dose | Biological | Administration: Inject intravenously 1X10^6 cells/kg per dose, four dose in total, weekly |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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