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VUM02 for Steroid-refractory Acute Graft-versus-host Disease
NCT06677255Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jan 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Modality
- Stem Cell Therapies
- Drugs
- VUM02
- Conditions
- Acute Graft-Versus-Host Disease (aGvHD)
01
Overview
Phase 2, randomised, open-label trial of VUM02 in Acute Graft-Versus-Host Disease (aGvHD) (4 arms), sponsored by Wuhan Optics Valley Zhongyuan Pharmaceutical. Primary endpoints: Occurrence of Dose-limiting toxicity events and Overall response rate. Planned start Jan 2025; status: not yet recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
Phase I Escalation
Single or Multiple doses of VUM02
Phase II: VUM02 Dose 1 + BAT
Selected Dose 1 of VUM02 + Best Available Therapy
Phase II: VUM02 Dose 2 + BAT
Selected Dose 2 of VUM02 + Best Available Therapy
Phase II: Control
Best Available Therapy only
03
Who it enrols
Patients aged 14-70 with steroid-refractory acute GvHD (Grade II-IV) after allogeneic HSCT. Excludes patients with severe organ dysfunction, active infections (HBV, HCV, HIV), or uncontrolled infections.
04
Endpoints
Primary
Occurrence of Dose-limiting toxicity events
Overall response rate
Secondary
Incidence and severity of cell therapy-related adverse events
Immunogenicity evaluation
Overall response rate, Complete response rate, and Durable complete response rate
Time to complete response and Time to partial response
Complete response rate and partial response rate in each involved organ
Cumulative relapse incidence of the primary disease
Overall survival and OS rate
Non-relapse mortality
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