A Study to Prevent Acute Graft-versus-Host Disease After Allogeneic Stem Cell Transplant in Adults at Moderate-to-High Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model

What this Trial Is About

Researchers are evaluating the use of recombinant humanized anti-CD25 monoclonal antibody injection to prevent severe acute graft-versus-host disease (aGVHD) in adult patients at moderate to high risk after allogeneic hematopoietic stem cell transplantation (allo-HSCT). This phase 2 study uses the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model to predict risk levels and aims to assess the safety and effectiveness of this antibody as a preventive treatment. Participants predicted at high risk by the model receive 50 mg/day of the antibody in the second week post-prediction, followed by 25 mg/day at the fourth and sixth weeks, combined with standard aGVHD prevention. Those at moderate risk receive 25 mg/day at the 2nd, 4th, and 6th weeks alongside conventional treatment. Low-risk patients receive only the conventional prevention regimen. During the study, researchers monitor the incidence of severe aGVHD within 100 days after transplantation as the primary outcome. Secondary outcomes include rates of aGVHD in target organs, engraftment, disease relapse, infections, overall survival, non-relapse mortality, chronic GVHD, treatment response, adverse events, and treatment costs up to 180 days post-transplant. Participants are followed closely with assessments throughout this period to evaluate the antibody's impact and safety.

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