Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS
NCT07567014 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-06
Summary
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.
Conditions
- Multiple Myeloma
- Large B-cell Lymphoma (LBCL)
Interventions
- DRUG
-
Emapalumab
1.0 mg/kg IV one day prior to bispecific antibody therapy
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Oscar B. Lahoud, MD · NYU Langone Health
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-11
- Primary Completion
- 2028-05-31
- Completion
- 2029-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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