Expanded Access Program for Lifileucel (LN-144) in Patients with Advanced Melanoma

Sponsor: Iovance Biotherapeutics, Inc.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05398640

Provider View

This program offers access to a treatment called Lifileucel (LN-144) for patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

This program provides access to Lifileucel (LN-144), a treatment for patients with advanced melanoma that cannot be removed by surgery or has spread. The treatment involves using a patient's own immune cells, which are grown and modified in a lab over 22 days, to help fight the cancer. Patients will receive a one-time infusion of these cells, along with other medications to prepare the body and support the treatment.

Description

Lifileucel (LN-144) is a type of cell therapy that uses a patient's own immune cells, called Tumor Infiltrating Lymphocytes (TILs), to target and fight melanoma. The process involves collecting these cells from the patient, growing and modifying them in a lab, and then infusing them back into the patient. This is done after a preparatory treatment to get the body ready, followed by a short course of a medication called IL-2 to help the cells work better. The goal is to provide a new treatment option for patients with advanced melanoma who have limited alternatives.

Eligibility Criteria

Inclusion Criteria

  • Have advanced melanoma that cannot be surgically removed or has spread (Stage IIIC/IIID/IV).
  • Have tried 1-4 previous treatments, including PD-1/PD-L1 therapies, without success or had to stop due to side effects.
  • May have had PD-1/PD-L1 therapy after surgery if the cancer returned within 6 months.
  • Have at least one tumor that can be removed to collect cells for the treatment.
  • Be 18 years or older.
  • Be in good general health with a life expectancy of at least 3 months.
  • Have good blood and organ function.
  • No other treatment options available.

Exclusion Criteria

  • Have had an organ transplant (except kidney) or previous cell therapies like TIL or CAR-T.
  • Have ongoing moderate to severe side effects from past immunotherapy (except certain conditions like vitiligo).
  • Have melanoma that started in the eye.
  • Have allergies to any part of the treatment.
  • Have untreated or unstable brain tumors.
  • Are on high-dose steroid therapy.
  • Have other serious medical conditions that increase risk.
  • Must test negative for syphilis and HIV; if positive for hepatitis B, must have undetectable viral load.
  • Have a primary immune deficiency.
  • Have received a live vaccine within 28 days before starting treatment.
  • Are pregnant or breastfeeding.

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