Preventing graft rejection after allogeneic stem cell transplant
Official title: Emapalumab for the Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients
Run by Children's Hospital Medical Center, Cincinnati · NCT07244419 · Data updated 2026-11-12
This trial will try the drug emapalumab to see if it can prevent graft rejection in people judged high risk after allogeneic hematopoietic stem cell transplant.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | emapalumab |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | June 2029 |
| Study ends | August 2029 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07244419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People undergoing allogeneic HSCT who are judged high risk for graft rejection by having two or more predefined risk factors (mismatched or haploidentical donor, ex vivo T-cell depleted graft, or prior graft rejection).
✕Probably not a fit
Patients who are not high risk for graft rejection, those with known hypersensitivity to the drug, or those with contraindications to additional immunomodulation 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 early-phase, single-center trial gives emapalumab, an anti–interferon-gamma antibody, as a preventive treatment to patients at high risk for graft rejection after allogeneic HSCT. Eligible patients are identified by having two or more risk factors (mismatched or haploidentical donor, ex vivo T-cell depleted graft, or prior graft rejection) and will be assigned to receive a prophylactic dose of emapalumab (3 mg/kg or 10 mg/kg). The protocol collects safety, pharmacokinetic/pharmacodynamic (PK/PD), and in vitro mechanistic data to inform dosing and to look for early signs that interferon-gamma blockade reduces graft failure. All treatments and follow-up occur at Cincinnati Children's Hospital Medical Center in partnership with Sobi.
Why it matters
Potential benefit: If successful, prophylactic emapalumab could reduce or prevent graft rejection and spare patients the risks of re-transplantation.
How similar studies have gone: Emapalumab is approved for interferon-gamma–driven hemophagocytic lymphohistiocytosis and shows target engagement, but using it prophylactically to prevent HSCT graft rejection is largely novel with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing allogeneic HSCT at our institution will be evaluated for graft rejection risk factors. Patients deemed high risk for graft rejection will have 2 or more of the following: mismatched or haploidentical donor, ex vivo t-cell depleted graft, prior history of graft rejection. Exclusion Criteria: * Known hypersensitivity to any constituent of the study medication.
Where it's running
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Anthony Sabulski, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Jessica Anderson, BSN, RN, CCRC
- Email: Jessica.Anderson@cchmc.org
- Phone: 513-636-4200
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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.