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A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

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Trial Profile

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

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

Latest Information Update: 21 Mar 2024

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At a glance

  • Drugs Lifileucel (Primary) ; Aldesleukin; Cyclophosphamide; Fludarabine
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms innovaTIL-01
  • Sponsors Iovance Biotherapeutics

    • Most Recent Events

    • 16 Feb 2024 According to an Iovance Biotherapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion.
    • 07 Nov 2023 According to an Iovance Biotherapeutics media release, following recent positive feedback from the European Medicines Agency (EMA) on Cohorts 2 and 4 of the C-144-01 clinical trial, Iovance plans to submit a marketing authorization application (MAA) in the European Union for lifileucel in advanced melanoma in the first half of 2024.
    • 24 Oct 2023 Results (n=15) assessing efficacy of Lifileucel tumor-infiltrating lymphocyte cell therapy in patients with advanced mucosal melanoma after progression on immune checkpoint inhibitors presented at the 48th European Society for Medical Oncology Congress
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