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NCT07244419EARLY_PHASE1Recruiting

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

Children's Hospital Medical Center, Cincinnati

Start Date

1/7/2026

Completion Date

8/1/2029

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.

Detailed Description

Graft rejection is a devastating and understudied complication of hematopoietic stem cell transplant (HSCT) due to the lack of available interventions outside of re-transplantation. Re-transplantation is challenging and is associated with increased morbidity and mortality. The purpose of this study is to learn more about emapalumab and its ability to prevent graft rejection in hematopoietic stem cell transplant (HSCT) recipients. Specifically, the study doctors would like to learn more about the efficacy and treatment of emapalumab as a prophylactic intervention for graft rejection.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DRUG

Emapalumab 3 mg/kg

DRUG

Emapalumab 10 mg/kg

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Conditions

Hematopoietic Stem Cell TransplantationGraft Failure

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States