Graft Versus Host DiseasePhase 1/2NCT05276076
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)
A Phase 1/2 study testing VM-001 1X10^6 cells/kg, VM-001 3X10^6 cells/kg and VM-001 5X10^6 cells/kg in people with Graft Versus Host Disease, run by ViGenCell Inc..
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- VM-001 1X10^6 cells/kg, VM-001 3X10^6 cells/kg and VM-001 5X10^6 cells/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2022to 20 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Graft Versus Host Disease
- Being tested
- 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
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM-001 1X10^6 cells/kgBiological
Administration: Inject intravenously single dose
VM-001 3X10^6 cells/kgBiological
Administration: Inject intravenously single dose
VM-001 5X10^6 cells/kgBiological
Administration: Inject intravenously single dose
VM-001 1X10^6 cells/kg two doseBiological
Administration: Inject intravenously
1X10^6 cells/kg per dose, two dose in total, weekly
VM-001 1X10^6 cells/kg four doseBiological
Administration: Inject intravenously
1X10^6 cells/kg per dose, four dose in total, weekly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: VM-001 1X10^6 cells/kg |
| 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. Receives: Biological: VM-001 3X10^6 cells/kg |
| 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. Receives: Biological: VM-001 5X10^6 cells/kg |
| 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. Receives: Biological: VM-001 1X10^6 cells/kg two dose |
| Part 2 Multiple Ascending Dose, Cohort 2 | Experimental | 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. Receives: Biological: VM-001 1X10^6 cells/kg four dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start20 Nov 2022 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViGenCell Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Ki Min, MD, Ph.D., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276076
- Sponsor's protocol ID
- VM-201
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05276076
- Acronym / sponsor ID
- VM-201
- Conditions
- Graft Versus Host Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- ViGenCell Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Ascending Dose, Cohort 1 | Experimental | Biological: VM-001 1X10^6 cells/kgCohort 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 1 Single Ascending Dose, Cohort 2 | Experimental | Biological: VM-001 3X10^6 cells/kgCohort 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. |
| Part 1 Single Ascending Dose, Cohort 3 | Experimental | Biological: VM-001 5X10^6 cells/kgCohort 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 | Experimental | Biological: VM-001 1X10^6 cells/kg two doseCohort 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 2 Multiple Ascending Dose, Cohort 2 | Experimental | Biological: VM-001 1X10^6 cells/kg four doseCohort 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VM-001 1X10^6 cells/kgAdministration: Inject intravenously single dose | Biological | Part 1 Single Ascending Dose, Cohort 1 |
| VM-001 3X10^6 cells/kgAdministration: Inject intravenously single dose | Biological | Part 1 Single Ascending Dose, Cohort 2 |
| VM-001 5X10^6 cells/kgAdministration: Inject intravenously single dose | Biological | Part 1 Single Ascending Dose, Cohort 3 |
| VM-001 1X10^6 cells/kg two doseAdministration: Inject intravenously 1X10^6 cells/kg per dose, two dose in total, weekly | Biological | Part 2 Multiple Ascending Dose, Cohort 1 |
| VM-001 1X10^6 cells/kg four doseAdministration: Inject intravenously 1X10^6 cells/kg per dose, four dose in total, weekly | Biological | Part 2 Multiple Ascending Dose, Cohort 2 |
Primary outcome
Maximum Tolerated Dose (MTD) of VM-001 [ Time Frame: 1 week ]
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Ki Min, MD, Ph.D. principal investigator
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VM-001 1X10^6 cells/kg, VM-001 3X10^6 cells/kg and VM-001 5X10^6 cells/kg in people with Graft Versus Host Disease, run by ViGenCell Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo Jung Park, Ph.D. (82-70-4348-7457, parkhyojung@vigencell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of VM-001 [ Time Frame: 1 week ] (time frame: 7 day cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.