RecruitingPhase 2NCT06880419

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

174 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Graft Versus Host Disease

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).

Eligibility

Min Age: 16 Years

Inclusion Criteria3

Age ≥ 16 years, regardless of gender.
Patients with hematologic disorders who are scheduled to receive allo-HSCT.
Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

Exclusion Criteria3

Patients who have received a second or multiple transplants.
Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.

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Interventions

DRUGRecombinant 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.