NCT06880419

Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model

A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Conditions

• Acute Graft-versus-Host Disease

Interventions

Type	Name	Description
DRUG	Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection	Model-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used.

Timeline

• Start date: 2025-03-03
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-03-17
• Last updated: 2025-08-08

Locations

1 site across 1 country: China