Study on Using LN-145 Cell Therapy for Patients with Advanced Non-Small-Cell Lung Cancer

Sponsor: Iovance Biotherapeutics, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04614103

Provider View

This clinical trial is testing a new cell therapy called LN-145 to see if it can help treat patients with advanced non-small-cell lung cancer (NSCLC) that has spread to other parts of the body.

Patient Parameters

Program Overview

The study is exploring a treatment called LN-145, which uses a patient's own immune cells to fight cancer. These cells are collected, grown in a lab, and then infused back into the patient. The process includes a special preparation phase to make room for the new cells, followed by the infusion of the cells and a medication called IL-2 to help the cells work better. The goal is to see if this approach can help control the cancer in patients with advanced NSCLC.

Description

LN-145 is a type of treatment that uses your own immune cells, known as tumor-infiltrating lymphocytes (TILs), to target and attack cancer cells. This therapy is specifically designed for patients with advanced non-small-cell lung cancer (NSCLC) that has spread to other parts of the body. The treatment involves several steps:

  1. Preparation: Patients receive a special treatment to prepare their body for the new cells. This helps create space for the TILs to grow and work effectively.

  2. Cell Infusion: The TILs, which are collected from the patient and grown in a lab, are infused back into the patient's body.

  3. Supportive Medication: After the infusion, patients receive a medication called IL-2, which helps the TILs survive and function better.

The study aims to determine if this combination can help control the cancer and improve outcomes for patients with metastatic NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Patients over 70 may join after consulting with the study team.
  • Must have a confirmed diagnosis of advanced Stage IV NSCLC without specific genetic changes (EGFR, ALK, or ROS1).
  • If other genetic changes are present, patients must have tried at least one targeted therapy.
  • Must have shown disease progression after initial treatments, including immunotherapy and chemotherapy.
  • Must have at least one tumor that can be removed for cell production and another that can be measured for response.
  • Must have good organ function and heart health (LVEF > 45%, NYHA Class 1).
  • Must have good lung function and be in good overall health (ECOG status 0 or 1).
  • Patients and partners of childbearing potential must agree to use effective birth control during and for 12 months after treatment.

Exclusion Criteria

  • Patients with specific genetic mutations (EGFR, ALK, or ROS1) are not eligible.
  • Patients with untreated brain cancer that is causing symptoms.
  • Patients who have had an organ transplant or cell therapy in the last 20 years.
  • Patients with immune system deficiencies.
  • Patients taking high doses of steroids (10 mg/day or more of prednisone or equivalent).
  • Patients who have received a live vaccine within 28 days before starting treatment.
  • Patients with another cancer diagnosis in the last 3 years.
  • Patients participating in another clinical trial within the last 21 days.

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