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A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

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Trial Profile

A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

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

Latest Information Update: 01 Oct 2024

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At a glance

  • Drugs Epcoritamab (Primary)
  • Indications B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms EPCORE NHL-1
  • Sponsors Genmab

    • Most Recent Events

    • 19 Aug 2024 According to an AbbVie media release, company announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, supported by data from the Phase 1/2 EPCORE NHL-1.
    • 19 Aug 2024 According to an AbbVie media release, company announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy, based on data from this study.
    • 23 Jul 2024 According to an AbbVie media release, company announced that Canada's Drug Agency (CDA, formerly CADTH) has issued its first-ever Time-Limited Reimbursement (TLR) recommendation for EPKINLY (epcoritamab) based on phase II data (EPCORE NHL-1).

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