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)

Launched by VIGENCELL INC. · Mar 2, 2022

Keywords

ClinConnect Summary

This clinical trial is designed to test a new treatment called VM-001 for patients with graft-versus-host disease (GvHD), a condition that can occur after a stem cell transplant where the donor's immune cells attack the recipient's body. The study aims to understand how safe the treatment is and how it affects the body over time. A total of 12 participants will be involved, and the trial will take place across multiple locations.

To be eligible for this trial, participants must be at least 19 years old, have either acute or chronic GvHD, and have run out of standard treatment options. They should also meet certain health requirements, such as having specific blood counts and liver function levels. The trial is currently not recruiting, but if someone joins, they can expect to be closely monitored throughout the 24 weeks of treatment, with regular check-ups to assess their health and the treatment's effects. It's important to note that individuals who have received certain treatments recently or have specific health issues, like active infections or pregnancy, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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.