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Recruiting EARLY_Phase 1 NCT07244419

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

Trial Parameters

Condition Hematopoietic Stem Cell Transplantation
Sponsor Children's Hospital Medical Center, Cincinnati
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 20
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2026-01-07
Completion 2029-06
Interventions
Emapalumab 3 mg/kgEmapalumab 10 mg/kg

Brief 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 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.

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