Preventing severe acute graft‑versus‑host disease in high‑risk adults with an anti‑CD25 antibody
Official title: 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
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT06880419 · Data updated 2026-11-12
This trial will try a recombinant humanized anti‑CD25 antibody to prevent severe aGVHD in adults the daGOAT model flags as intermediate‑to‑high risk after allogeneic stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | March 3, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT06880419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 16 and older with hematologic disorders scheduled for allo‑HSCT who are identified as intermediate‑to‑high risk by the daGOAT model and who can give informed consent and comply with follow‑up are the ideal candidates.
✕Probably not a fit
Patients who have had multiple transplants, who are pregnant or breastfeeding, or who are allergic to the anti‑CD25 antibody (or are classified as low risk by daGOAT) are unlikely to benefit from this prophylactic approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, interventional study enrolling adults (age ≥16) with hematologic disorders who are scheduled for allogeneic hematopoietic stem cell transplantation and identified as intermediate‑to‑high risk for aGVHD by the daGOAT model. Participants will receive prophylactic recombinant humanized anti‑CD25 monoclonal antibody injections in addition to standard transplant care, with monitoring for aGVHD incidence and safety outcomes. The primary focus is on whether the antibody lowers the rate of severe aGVHD and on its tolerability in this selected risk group. The trial is conducted at the Institute of Hematology & Blood Diseases Hospital in Tianjin, China.
Why it matters
Potential benefit: If successful, this approach could lower the incidence of severe aGVHD after allo‑HSCT and reduce transplant‑related complications.
How similar studies have gone: Similar anti‑CD25 antibody approaches have been tested for prevention or treatment of aGVHD in prior studies with mixed results, so this strategy builds on existing but not definitive evidence.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: erlie jiang
- Email: jiangerlie@ihcams.ac.cn
- Phone: +86-15122538106
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial will test whether giving a single-unit unrelated umbilical cord blood transplant at different times of day changes the chance of acute graft-versus-host disease in people with malignant blood disorders who are in remission.
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Ruxolitinib treatment for acute graft-versus-host disease
This study is testing if ruxolitinib can help people with acute graft-versus-host disease who haven't improved with regular steroid treatments.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.