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

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

Recruiting
16 years and older
All
Phase 2

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Overview

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details
    Acute Graft-versus-Host Disease

NCT06880419

Institute of Hematology & Blood Diseases Hospital, China

16 August 2025

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