RecruitingPhase 2NCT02133196

T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen


Sponsor

National Cancer Institute (NCI)

Enrollment

85 participants

Start Date

Oct 23, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe. Eligibility: \- Adults age 18-72 with NSCLC who have a tumor that can be safely removed. Design: * Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed * Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. * Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} * Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days. ...


Eligibility

Min Age: 18 YearsMax Age: 72 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a type of personalized immune therapy called T cell receptor (TCR) immunotherapy, where immune cells (T cells) are taken from a patient's own tumor, grown in large numbers in the lab, and then put back into the patient to fight advanced non-small cell lung cancer (NSCLC) that has stopped responding to other treatments. **You may be eligible if...** - You are between 18 and 72 years old - You have stage IV (metastatic) or inoperable non-small cell lung cancer - You have already received at least one standard treatment and your cancer has continued to grow - Your performance status is good (ECOG 0 or 1 — able to carry out normal activities) - Your blood counts and organ function are at acceptable levels - You have a tumor site that can be surgically removed to harvest immune cells **You may NOT be eligible if...** - You have neuroendocrine lung tumors - You are pregnant or breastfeeding - You are unwilling to use birth control during and after the study - You have certain active autoimmune conditions or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAldesleukin

Aldesleukin 720,000 (Arm 1) or 72,000 (Arm 2) IU/kg IV (based on total body weight) over 15 minutes every 8 hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to a maximum of 9 doses in Arm 1 and 12 doses in Arm 2.

DRUGFludarabine

Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

DRUGCyclophosphamide

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hour.

BIOLOGICALYoung TIL

Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT02133196


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