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

Phase 2

Not yet recruiting

• Conditions: Acute Graft-versus-Host Disease
• Interventions: Drug: Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection

• Registration Number: NCT06880419
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The group of daGOAT model prevention	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.

Primary Outcome Measures

Name	Time	Method
Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation	100 days after transplantation

Secondary Outcome Measures

Name	Time	Method
Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation	100 days after transplantation
Engraftment rate	180 days after transplantation
Disease relapse rate	180 days after transplantation
Infection rate	180 days after transplantation
Overall survival	180 days after transplantation
Non-relapse mortality	180 days after transplantation
GVHD-free relapse-free survival	180 days after transplantation
Overall Response Rate of severe aGVHD treatment	100 days after transplantation
Incidence of chronic GVHD	180 days after transplantation
Adverse events	180 days after transplantation
Total cost of treatment	180 days after transplantation