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

NCT06880419 | Recruiting Phase 2

• 1 other identifier: IIT2024115
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Graft-versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation

  100 days after transplantation

Secondary Outcomes (11)

• 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

Study Arms (1)

The group of daGOAT model prevention

EXPERIMENTAL

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.

Drug: Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection

Interventions

Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection DRUG

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.

The group of daGOAT model prevention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Central Study Contacts

erlie jiang

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

yigeng cao

CONTACT

+86-18622477066; caoyigeng@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: March 3, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)