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Multiple MyelomaPhase 2NCT07567014

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

A Phase 2 study testing Emapalumab in people with Multiple Myeloma and Large B-cell Lymphoma (LBCL), run by NYU Langone Health at 3 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Emapalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesUnited States
Study dates
11 May 2026to 31 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • Absolute neutrophil count (ANC) ≥ 1000/µL,
  • Platelet count ≥ 50,000/µL,
  • Hgb > 7, and standard pre-medications are allowed per standard of care guidelines
  • Patients eligible to receive the bispecifics per institutional guidelines.
  • Absolute lymphocyte count ≥ 100/µL
  • Creatinine clearance (as estimated by Cockcroft Gault or CKD-EPI) ≥ 30 mL/min,
  • Serum ALT/AST ≤ 2.5 times institutional upper limit of normal (ULN),
  • Total bilirubin ≤ 1.5 mg/dL, except in subjects with Gilbert's syndrome,
  • Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion, and no clinically significant ECG findings (current status)
  • Baseline oxygen saturation > 92% on room air.
  • Reproductive Status:
  • Females of childbearing potential must have a negative serum or urine pregnancy test. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
  • Women of Childbearing Potential (WOCBP) must agree to use one highly effective method of contraception, including hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstain from heterosexual intercourse for the duration of study participation and for six months after the last bispecific antibody dose..
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment.
  • 6. Consent:
  • Ability to understand and willingness to sign a written informed consent document

Who cannot join

  • Other Malignancies:
  • 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.
  • 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.
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  • 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:
  • 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.
  • History of symptomatic pulmonary embolism within 3 months of enrollment (ongoing anticoagulation is allowed if beyond 3 months).
  • Autoimmune Disease:
  • History of autoimmune disease requiring ongoing systemic immunosuppression. Steroids are allowed up to 5mg prednisone-equivalent for adrenal insufficiency.
  • Patients anticipated to require canakinumab, Janus kinase (JAK) inhibitors, Tumor necrosis factor (TNF) inhibitors, or tocilizumab for baseline autoimmune/inflammatory disease at the time of bispecific antibody therapy initiation.
  • Vaccination:
  • Receipt of a Bacillus Calmette-Guérin (BCG) vaccine within 12 weeks prior to screening.
  • Receipt of any live or attenuated live vaccine (other than BCG) within 4 weeks prior to screening.
  • Investigational Agents:
  • Participants receiving any other investigational agents for their condition.
  • Pregnancy or Breastfeeding:
  • Females who are pregnant or breastfeeding, or participants unwilling to use birth control during the study and for 6 months after bispecific therapy.
  • Inability to Participate:
  • In the investigator's judgment, subjects unlikely to complete all protocol required study visits or procedures, including follow-up visits, or comply with study participation requirements.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oscar B. Lahoud, MD contact

646-754-8570

Oscar.lahoud@nyulangone.org

Gabrielle Gargano, BS, CCRC contact

718-753-8948

Gabrielle.Gargano@nyulangone.org

United States3 sites

  • NYU Langone Health Perlmutter Cancer Center - Sunset Park

    Brooklyn, New York, 11220

  • NYU Langone Health Perlmutter Cancer Center - Manhattan

    Manhattan, New York, 10016

  • NYU Langone Health - Long Island

    Mineola, New York, 11501

Other trials in United States

About this study

Official title: A Phase II Study of the Interferon Gamma Inhibitor Emapalumab for Prophylaxis of Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome in Patients With Lymphoma and Multiple Myeloma Receiving Bispecific T-Cell Engagers

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.

Being tested
Emapalumab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmapalumabDrug

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

Study groups in NCT07567014
Study groupRoleWhat they receive
Prophylactic EmapalumabExperimentalParticipants will receive the investigational IFN-У inhibitor Emapalumab prior to the intended standard bispecific antibody therapy for lymphoma and multiple myeloma.
Receives: Drug: Emapalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 30 days of treatment

Secondary outcomes (8)

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

    Measured: Within 30 days of treatment

  2. Mean CRS grade

    Cytokine release syndrome (CRS) grades range from 2-5, the higher the grade the more severe the event.

    Measured: Within 30 days of treatment

  3. Mean ICANS grade

    Immune effector cell-associated neurotoxicity syndrome (ICANS) grades range from 2-5, the higher the grade the more severe the event.

    Measured: Within 30 days of treatment

  4. Number of participants with grade 3 or higher CRS

    Measured: Within 30 days of treatment

  5. Number of participants with grade 3 or higher ICANS

    Measured: Within 30 days of treatment

  6. Number of participants with any grade non-hematologic adverse events (AEs)

    Measured: Within 30 days of treatment

  7. Number of participants with grade hematologic AEs

    Measured: Within 30 days of treatment

  8. Number of participants hospitalized within 30 days of treatment

    Measured: Within 30 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start11 May 2026 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567014
Sponsor's protocol ID
25-00098
Status last verified
May 2026
First submitted
28 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Oscar.lahoud@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Emapalumab in people with Multiple Myeloma and Large B-cell Lymphoma (LBCL), run by NYU Langone Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oscar B. Lahoud, MD (646-754-8570, Oscar.lahoud@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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