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Anti-CD25 mAb for aGVHD Prevention with daGOAT Model
NCT06880419Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2025
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Institute of Hematology and Blood Diseases Hospital
- Modality
- Monoclonal Antibodies
- Drugs
- xenopax
- Conditions
- Acute Graft-Versus-Host Disease (aGvHD)
01
Overview
Phase 2, open-label, single-arm trial of xenopax in Acute Graft-Versus-Host Disease (aGvHD), sponsored by Institute of Hematology and Blood Diseases Hospital. Primary endpoint: Incidence of severe aGVHD (Grade III-IV) at 100 days. Started Mar 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
The group of daGOAT model prevention
Single arm stratified by daGOAT model risk. High/Moderate risk receive Xenopax; Low risk receive SOC.
03
Who it enrols
Adult patients (>=16 years) with hematologic disorders scheduled for allo-HSCT, excluding those with prior transplants or allergy to anti-CD25 mAb.
04
Endpoints
Primary
Incidence of severe aGVHD (Grade III-IV)
Secondary
Incidence of aGVHD and aGVHD (any grade) in each target organ
Engraftment rate
Disease relapse rate
Infection rate
Overall survival
Non-relapse mortality
GVHD-free relapse-free survival
Overall Response Rate of severe aGVHD treatment
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