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 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)

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.

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.