Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS (NCT07567014) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS
United States60 participantsStarted 2026-05-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
What they're measuring
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.
. 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:
Exclusion criteria
✕. Other Malignancies:
✕. 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.