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
Price :
$35
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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
- 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