NCT06880419 Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model
| NCT ID | NCT06880419 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Acute Graft-versus-Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 174 participants in total. It began in 2025-03-03 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06880419 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Acute Graft-versus-Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06880419 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06880419 currently recruiting?
Yes, NCT06880419 is actively recruiting participants. Contact the research team at jiangerlie@ihcams.ac.cn for enrollment information.
Where is the NCT06880419 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06880419 clinical trial?
NCT06880419 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 174 participants.