A Phase II Study of Autologous Tumor-Infiltrating Lymphocyte Immunotherapy in People with Metastatic Melanoma or Lung Cancer

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Full Title

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/ LN-145/LN-145-S1) in Patients with Solid Tumors

Purpose

This study is assessing an investigational immunotherapy called “autologous tumor-infiltrating lymphocytes” (TIL). It is made from the white blood cells (lymphocytes or T cells) that come from a piece of a patient’s own tumor removed during surgery. The TILs are developed further in a laboratory, then delivered back to the patient several weeks later. TIL treatments are designed to help the immune system destroy cancer cells.

In this study, researchers are evaluating the safety and effectiveness of TILs (LN-145 and LN-145-S1) in patients with metastatic melanoma or non-small cell lung cancer (NSCLC). They will assess TILs alone or in combination with the immunotherapy drug pembrolizumab. LN-145, LN-145-S1, and pembrolizumab are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic stage IIIC or IV melanoma of the skin, or stage III or IV NSCLC.
  • Patients must have an accessible tumor lesion that can be removed by surgery to be able to collect TILs.
  • Patients should recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Adam Schoenfeld in the office of Dr. Matthew Hellmann at 646-888-4863.

Protocol

20-154

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators