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A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

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Trial Profile

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 Mar 2024

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At a glance

  • Drugs Teclistamab (Primary) ; Teclistamab (Primary)
  • Indications Multiple myeloma
  • Focus Adverse reactions; First in man; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms MajesTEC-1
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 27 Feb 2024 Planned End Date changed from 27 Mar 2026 to 22 Jul 2026.
    • 27 Feb 2024 Planned End Date changed from 27 Mar 2026 to 22 Jul 2026.
    • 20 Feb 2024 According to a Johnson & Johnson media release, based on results from MajesTEC-1 study Phase 1: NCT03145181; Phase 2: NCT04557098, the U.S. FDA has approved the supplemental Biologics License Application (sBLA) for TECVAYLIs (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.
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