Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 16 and up

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.

More Acute Graft Versus Host Disease trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages16 Years and up
SexAll
Enrollment174 (estimated)
SponsorInstitute of Hematology & Blood Diseases Hospital, China
Academic / other
Locations1 site (Tianjin, Tianjin Municipality)
StatusRecruiting
StartedMarch 3, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedAugust 8, 2025
Trial IDNCT06880419 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

  • Institute of Hematology & Blood Diseases Hospital
    Tianjin, Tianjin Municipality, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.