Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS

Part of paid clinical trials in Brooklyn, New York.

Sponsor
NYU Langone Health
Study ID
NCT07567014
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Emapalumab — DRUG
    1.0 mg/kg IV one day prior to bispecific antibody therapy

Study Details

The purpose of this study is to evaluate emapalumab as a prophylactic therapy in preventing cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients with hematologic malignancies receiving bispecific antibodies (BsAbs) as outpatient. The primary objectives of this study are to evaluate the efficacy, safety, and feasibility of prophylaxis with the interferon gamma (IFN-У -γ) inhibitor Emapalumab in preventing CRS and/or ICANS in patients receiving bispecific antibody therapy for hematologic malignancies.

Key Dates

Start date
May 11, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prophylactic Emapalumab
    Participants will receive the investigational IFN-У inhibitor Emapalumab prior to the intended standard bispecific antibody therapy for lymphoma and multiple myeloma.

Primary Outcome Measure

Number of participants with cytokine release syndrome (CRS) (grades 2-5, as per ASTCT criteria) and/or immune effector cell-associated neurotoxicity syndrome (ICANS) (grades 2-5, per ASTCT criteria) within 30 days of bispecific antibody administration. [ Time Frame: Within 30 days of treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NYU Langone Health Perlmutter Cancer Center - Sunset ParkBrooklynNew York11220-
NYU Langone Health Perlmutter Cancer Center - ManhattanManhattanNew York10016-
NYU Langone Health - Long IslandMineolaNew York11501-

Find similar trials in Brooklyn, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
NYU Langone Health Perlmutter Cancer Center - Sunset Park· Brooklyn, NYNYU Langone Health Perlmutter Cancer Center - Manhattan· Manhattan, NYNYU Langone Health - Long Island· Mineola, NY

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