Preventing severe acute graft‑versus‑host disease in high‑risk adults with an anti‑CD25 antibody
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
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 |
| Enrollment | 174 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06880419 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tianjin, Tianjin Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.