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An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)

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Trial Profile

An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)

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

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs Odronextamab (Primary) ; Odronextamab (Primary) ; Rituximab (Primary)
  • Indications Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions; First in man; Proof of concept; Registrational; Therapeutic Use
  • Acronyms ELM-1
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 26 Feb 2025 According to a Regeneron Pharmaceuticals media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2). The target action date for the FDA decision is July 30, 2025.
  • 09 Dec 2024 According to a Regeneron Pharmaceuticals media release, data from this study presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA.
  • 13 Nov 2024 According to a Regeneron Pharmaceuticals media release, data from this trial will be presented at the American Society of Hematology (ASH) 2024 Annual Meeting

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