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RECRUITING
NCT07244419
EARLY_PHASE1

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

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-01-07

Completion Date

2029-08

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DRUG

Emapalumab 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.

DRUG

Emapalumab 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