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

Conditions

• Graft Failure
• Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Emapalumab 3 mg/kg — DRUG
  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.
• Emapalumab 10 mg/kg — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jan 7, 2026

Status verified

Jan 2026

Primary completion

Jun 30, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Emapalumab 3 mg/kg
  Patients randomized to this arm will receive 3mg/kg of emapalumab intravenously (IV) once on day +1 after HSCT. Up to two additional, 10mg/kg rescue doses may be administered if patients developed signs and symptoms of acute graft rejection. Rescue dose administration decisions will be made in consultation with the lead study investigator. Emapalumab is a ligand-based therapy, which means high levels of circulating ligand (i.e. interferon gamma) will rapidly consume the drug. For these reasons, rescue doses may be given as early as 24 hours from the prior dose.
• Active Comparator: Emapalumab 10 mg/kg
  Patients randomized to this arm will receive 10mg/kg of emapalumab intravenously (IV) once on day +1 after HSCT. Up to two additional, 10mg/kg rescue doses may be administered if patients developed signs and symptoms of acute graft rejection. Rescue dose administration decisions will be made in consultation with the lead study investigator. Emapalumab is a ligand-based therapy, which means high levels of circulating ligand (i.e. interferon gamma) will rapidly consume the drug. For these reasons, rescue doses may be given as early as 24 hours from the prior dose.

Primary Outcome Measure

Preliminary efficacy of Emapalumab [ Time Frame: 100 days ]

Central Contacts

• Jessica Anderson, BSN, RN, CCRC
  513-636-4200
  [email protected]
• Manisha Pathak, MS
  513-636-4200
  [email protected]

Locations (1)

Find similar trials in Cincinnati, OH

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