A Pilot Study of Lifileucel in People with Metastatic Melanoma to the Brain that Is Not Causing Symptoms

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Full Title

A Pilot Trial of Lifileucel (LN-144) for Patients with Asymptomatic Melanoma Brain Metastases and Progression on Prior PD-1 Therapy

Purpose

The purpose of this study is to see if it is practical to use a treatment called lifileucel in people with melanoma that has continued to grow despite immunotherapy and/or targeted therapy and has spread to the brain, but is not causing symptoms. Lifileucel (also called LN-144) is called “autologous tumor-infiltrating lymphocytes” (TIL) therapy. TIL therapies are made in a laboratory from white blood cells called lymphocytes (or T cells) that are collected from a patient’s tumor during a surgical procedure. Lifileucel is designed to selectively attack cancer cells while leaving healthy cells alone.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have brain metastases from melanoma that are not causing any symptoms.
  • Patients must have melanoma that continued to grow despite prior immunotherapy and/or targeted therapy.
  • To produce lifileucel, participants must have at least one tumor 1.5 cm or more in size that can be surgically removed.
  • The serious side effects of previous therapies should go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to see if you can join this study, please call Dr. Alexander Shoushtari’s office 646-888-4161.

Protocol

22-322

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

ClinicalTrials.gov ID

NCT05640193