Status:
UNKNOWN
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)
Lead Sponsor:
ViGenCell Inc.
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05276076
Start Date
November 20 2022
End Date
November 20 2025
Last Update
March 11 2022
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