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Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

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Trial Profile

Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Linvoseltamab (Primary) ; Linvoseltamab (Primary)
  • Indications Multiple myeloma
  • Focus Adverse reactions; First in man; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms LINKER-MM1
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 07 Apr 2024 Results published in the Regeneron Pharmaceuticals Media Release
    • 21 Feb 2024 According to a Regeneron Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target action date for the FDA decision is August 22, 2024.
    • 02 Feb 2024 According to a Regeneron Pharmaceuticals media release, Linvoseltamab was administered with an initial step-up dosing regimen followed by the full dose. The Phase 1 intravenous dose-escalation portion of the trial, is now complete.
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