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)
Phase 1
Not yet recruiting
- Conditions
- Graft Versus Host Disease
- Interventions
- Biological: VM-001 1X10^6 cells/kgBiological: VM-001 1X10^6 cells/kg four doseBiological: VM-001 5X10^6 cells/kgBiological: VM-001 1X10^6 cells/kg two doseBiological: VM-001 3X10^6 cells/kg
- Registration Number
- NCT05276076
- Lead Sponsor
- ViGenCell Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1 Single Ascending Dose, Cohort 1 VM-001 1X10^6 cells/kg 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. Part 2 Multiple Ascending Dose, Cohort 2 VM-001 1X10^6 cells/kg four dose 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. Part 1 Single Ascending Dose, Cohort 3 VM-001 5X10^6 cells/kg Cohort 3 : 5X10\^6 cells/kg The safety of 2 subjects is evaluated for 1 week after single dose of IP. Part 2 Multiple Ascending Dose, Cohort 1 VM-001 1X10^6 cells/kg two dose 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. Part 1 Single Ascending Dose, Cohort 2 VM-001 3X10^6 cells/kg 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.
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of VM-001 [ Time Frame: 1 week ] 7 day cycle 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
Name Time Method