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An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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Trial Profile

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Mar 2024

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At a glance

  • Drugs Odronextamab (Primary)
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ELM-2
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 25 Mar 2024 According to a Regeneron Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy.
    • 12 Dec 2023 Results of pooled analysis (n=507 from studies ELM-1 and ELM-2) assessing pharmacokinetics, pharmacodynamics, and exposure-response analyses for efficacy and safety of Odronextamab Monotherapy for the Treatment of Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 12 Dec 2023 Results of subgroup analysis assessing Molecular characterization of B-cell non-Hodgkin lymphoma (B-NHL), through circulating tumor DNA (ctDNA) assessment of minimal residual disease (MRD) presented at the 65th American Society of Hematology Annual Meeting and Exposition
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