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

NCT07567014 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-00098
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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)

Outcome Measures

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.

  Within 30 days of treatment

Secondary Outcomes (8)

• Time to onset of first occurrence of CRS/ICANS by grades 2-5

  Within 30 days of treatment

• Mean CRS grade

  Within 30 days of treatment

• Mean ICANS grade

  Within 30 days of treatment

• Number of participants with grade 3 or higher CRS

  Within 30 days of treatment

• Number of participants with grade 3 or higher ICANS

  Within 30 days of treatment

Study Arms (1)

Prophylactic Emapalumab

EXPERIMENTAL

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

Drug: Emapalumab

Interventions

Emapalumab DRUG

1.0 mg/kg IV one day prior to bispecific antibody therapy

Prophylactic Emapalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease Criteria:
• Adult patients (≥18 years) with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapsed after first-line chemoimmunotherapy not eligible for high-dose therapy/autologous stem cell transplantation (HDT-ASCT) or Chimeric Antigen Receptor T- cell (CAR-T) therapy, or adult patients with relapsed/refractory (R/R) LBCL after two or more lines of systemic therapy, who are planned to receive a commercially approved bispecific antibody therapy (e.g. epcoritamab, glofitamab). This includes:
• 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.
• Adult patients with R/R multiple myeloma (MM) who have received multiple lines of therapy and are planned to receive a commercially approved bispecific antibody therapy. These prior therapies will typically include a proteasome inhibitor (e.g., bortezomib, carfilzomib), an immunomodulatory drug (e.g., lenalidomide, pomalidomide), and an anti-CD38 monoclonal antibody (e.g., daratumumab).
• Treatment Eligibility:
• At least measurable disease per Lugano Criteria (for B-cell lymphomas) or per International Myeloma Working Group (IMWG) criteria (for multiple myeloma) at the time of screening.
• At least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy at the time the subject is planned for bispecific antibody therapy, except for systemic inhibitory/stimulatory immune checkpoint therapy. Steroids require only a 7-day washout.
• At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.) before the planned bispecific therapy.
• Performance Status:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Organ Function:
• Adequate renal, hepatic, pulmonary, and cardiac function, defined as:

You may not qualify if:

• Other Malignancies:
• a. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free for at least 2 years.
• b. History of Richter's transformation of chronic lymphocytic leukemia (CLL).
• Stem Cell Transplantation:
• 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.
• Infections:
• 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.
• Patients must be negative for tuberculosis (TB). Subjects positive for latent tuberculosis prior to study must be started on or have completed with appropriate treatment prior to emapalumab infusion.
• Patients must be negative for active cytomegalovirus (CMV, NAT), Epstein-Barr virus (EBV, NAT), and adenovirus (NAT) by PCR testing.
• Central nervous system (CNS) Disorders:
• a. Evidence of active CNS disease, regardless of prior CNS history. b. History or presence of CNS disorder such as seizure disorder or cerebrovascular ischemia/hemorrhage within 6 months of enrollment.
• Cardiac and Pulmonary Events:
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (3)

NYU Langone Health Perlmutter Cancer Center - Sunset Park

Brooklyn, New York, 11220, United States

Location

NYU Langone Health Perlmutter Cancer Center - Manhattan

Manhattan, New York, 10016, United States

Location

NYU Langone Health - Long Island

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Emapalumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Oscar B. Lahoud, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar B. Lahoud, MD

CONTACT

646-754-8570; Oscar.lahoud@nyulangone.org

Gabrielle Gargano, BS, CCRC

CONTACT

718-753-8948; Gabrielle.Gargano@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Oscar.lahoud@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (3)