RecruitingEarly Phase 1NCT07244419

Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients

Emapalumab for the Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

20 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators hypothesize that graft rejection after hematopoietic stem cell transplant (HSCT) is primarily driven by interferon gamma, and prophylactic interferon gamma inhibition in high-risk patients will prevent graft rejection. Additionally, knowledge of emapalumab PK/PD and in vitro mechanistic effects of emapalumab in this novel setting will guide optimization of dosing regimens and treatment approaches in future studies.


Eligibility

Inclusion Criteria1

  • 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 Criteria1

  • Known hypersensitivity to any constituent of the study medication.

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Interventions

DRUGEmapalumab 3 mg/kg

Subjects will be randomized to either receive a 3mg/kg or 10mg/kg intravenous dose of emapalumab once and may receive up to two additional doses if clinical concern for impending graft rejection develops.

DRUGEmapalumab 10 mg/kg

Subjects will be randomized to either receive a 3mg/kg or 10mg/kg intravenous dose of emapalumab once and may receive up to two additional doses if clinical concern for impending graft rejection develops.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT07244419


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