Study on Using Tumor Infiltrating Lymphocytes for Treating Advanced Solid Cancers

Sponsor: Udai Kammula

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03935893

Provider View

This clinical trial is testing a new treatment that uses a patient's own immune cells, called tumor infiltrating lymphocytes (TILs), to fight advanced solid cancers. The study aims to see if this approach is effective in shrinking tumors in patients with various types of advanced cancers.

Patient Parameters

Program Overview

This study is exploring a treatment that involves using a patient's own immune cells, known as tumor infiltrating lymphocytes (TILs), to target and attack advanced solid cancers. The treatment process includes preparing the body with specific medications, infusing the TILs, and administering a high dose of a drug called aldesleukin. The goal is to determine if this method can effectively reduce tumors in patients with certain types of advanced cancers, such as gastric, colorectal, pancreatic, and others, who have not responded to standard treatments.

Description

In this study, researchers are testing a new treatment for advanced solid cancers using a patient's own immune cells, called tumor infiltrating lymphocytes (TILs). These cells are collected from the patient's tumor, grown and expanded in the lab, and then infused back into the patient to help fight the cancer.

The treatment involves several steps:

  1. Cell Preparation: Patients with certain types of advanced cancers will have a small piece of their tumor removed to collect TILs. These cells are then grown in the lab to increase their numbers and tested for their ability to fight cancer.

  2. Treatment Phase: Once the TILs are ready, patients will receive medications to prepare their body, followed by an infusion of the TILs and a high dose of aldesleukin, a drug that helps boost the immune response. After about six weeks, patients will undergo evaluations to see how well the treatment is working and to check for any side effects.

Patients may receive a second round of treatment if needed, but no other experimental treatments will be given during this study.

Eligibility Criteria

Inclusion Criteria

  • Have a measurable, advanced cancer that is locally advanced, recurrent, or has spread to other parts of the body, and is one of the following types: gastric/esophagogastric, colorectal, pancreatic, sarcoma, mesothelioma, neuroendocrine, squamous cell, Merkel cell, or cancers with specific genetic features.
  • Have tried all standard treatments available for their cancer type.
  • Be 18 to 75 years old.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than three months.
  • Agree to use birth control during the study and for up to four months after treatment.
  • Test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control with appropriate treatments.
  • Have adequate blood cell counts and organ function as indicated by specific blood tests.
  • Have not received any cancer treatments for at least four weeks before starting the study.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Women who are pregnant or breastfeeding due to potential risks to the baby.
  • Have primary immunodeficiency disorders.
  • Have active infections or other serious medical conditions.
  • Have a history of severe allergic reactions to any of the study drugs.
  • Have significant heart or lung problems, such as low heart function or respiratory issues.
  • Are currently taking systemic steroids or other investigational drugs.

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