Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diffuse large B-cell lymphoma (DLBCL) not otherwise specified,
Primary mediastinal large B-cell lymphoma,
High-grade B-cell lymphoma,
DLBCL arising from follicular lymphoma.
Disqualifiers
Autologous stem cell transplant within 6 weeks of planned bispecific antibody therapy.
History of allogeneic stem cell transplantation within 6 months of planned bispecific antibody.
Presence of uncontrolled fungal, bacterial, viral, or other infections at the time of screening.
Patients with uncontrolled hepatitis B or C infection. Subjects with positive Hepatitis B or C serology should be started on appropriate antiviral therapy prior to Emapalumab infusion.
Trial design
Design model
Single group
Treatments tested in this trial
Emapalumab
Drug1.0 mg/kg IV one day prior to bispecific antibody therapy
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Prophylactic EmapalumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
Time to onset of first occurrence of CRS/ICANS by grades 2-5
Time frame
Within 30 days of treatment2
Mean CRS grade
Cytokine release syndrome (CRS) grades range from 2-5, the higher the grade the more severe the event.
Time frame
Within 30 days of treatment3
Mean ICANS grade
Immune effector cell-associated neurotoxicity syndrome (ICANS) grades range from 2-5, the higher the grade the more severe the event.
Time frame
Within 30 days of treatment4
Number of participants with grade 3 or higher CRS
Time frame
Within 30 days of treatmentSponsors and contacts
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Source ClinicalTrials.gov
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