Study on Using Tumor Infiltrating Lymphocytes for Treating Biliary Tract Cancers

Sponsor: Udai Kammula

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03801083

Provider View

This clinical trial is testing a new treatment approach using a patient's own immune cells, called Tumor Infiltrating Lymphocytes (TIL), to fight biliary tract cancers. The study aims to see if this method can help control cancer that is advanced, has returned, or has spread.

Patient Parameters

Program Overview

This Phase 2 study is exploring a treatment for biliary tract cancers, including cholangiocarcinoma and gallbladder cancer, using a patient's own immune cells called Tumor Infiltrating Lymphocytes (TIL). These cells are collected, grown in a lab, and then infused back into the patient after a special chemotherapy regimen. The goal is to see if this approach can help shrink tumors in patients with advanced, recurrent, or metastatic biliary tract cancer.

Description

In this study, patients with advanced biliary tract cancers will have a sample of their tumor taken to collect Tumor Infiltrating Lymphocytes (TIL). These immune cells are then grown and expanded in a lab. Once enough cells are ready, patients will receive a chemotherapy regimen to prepare their body, followed by an infusion of the TIL and a medication called aldesleukin to help the cells work better.

The treatment aims to boost the body's immune response against cancer. After the infusion, patients will be monitored for about six weeks to evaluate the treatment's effectiveness and any side effects. If the first attempt to grow TIL is unsuccessful, a second tumor sample may be taken if possible.

Patients will receive one course of treatment, starting with chemotherapy and ending with the first evaluation after TIL infusion. A second course may be considered if needed. No other experimental treatments will be given during this study.

Eligibility Criteria

Inclusion Criteria

  • Have advanced, recurrent, or metastatic biliary tract cancer, including cholangiocarcinoma or gallbladder cancer.
  • Cancer must be inoperable by standard surgery or have spread and not responded to standard treatments like gemcitabine or cisplatin.
  • Must be enrolled in a related study for cell preparation and have TIL available for treatment.
  • Can have up to three small, stable brain tumors that are not causing symptoms.
  • Aged between 18 and 75 years.
  • Able to understand and sign consent forms.
  • In good general health with a performance status of 0 or 1.
  • Expected to live more than three months.
  • Agree to use birth control during and for four months after treatment.
  • Test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Have adequate blood counts and organ function as determined by specific tests.
  • At least four weeks since any previous cancer treatment, with recovery from side effects.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have primary immune system deficiencies.
  • Have active infections or serious medical conditions.
  • Have a history of significant autoimmune diseases.
  • Currently taking systemic steroids.
  • Have severe allergies to study medications.
  • Have heart problems or low heart function.
  • Have significant lung problems or a history of heavy smoking.
  • Currently participating in another clinical trial or taking investigational drugs.

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