Study on TROP2 CAR-Engineered Cord Blood-Derived NK Cells and Belzutifan for Pancreatic Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07377526

Provider View

This clinical trial is testing a new treatment combining TROP2 CAR-engineered NK cells with the drug belzutifan for patients with advanced pancreatic cancer. The study aims to determine the safety and best dose of this combination therapy.

Patient Parameters

Program Overview

This study is exploring a new treatment for pancreatic cancer that involves using specially engineered immune cells called TROP2 CAR NK cells, along with a drug called belzutifan. The treatment is given directly into the abdomen and aims to help fight cancer that has returned, spread, or cannot be removed by surgery. The main goals are to ensure the treatment is safe and to find the best dose for future studies.

Description

The primary goal of this study is to determine if the combination of TROP2 CAR NK cells and belzutifan is safe for patients with advanced pancreatic cancer. The treatment involves delivering these engineered immune cells directly into the abdomen and taking belzutifan orally. Researchers will monitor for any side effects and determine the best dose for future studies.

Secondary goals include assessing how well the treatment works in shrinking tumors, how long patients live without the cancer getting worse, and overall survival rates. The study will also look at how the treatment affects the cancer environment in the body and track changes in tumor DNA in the blood. Patients will report on their symptoms and quality of life throughout the study.

Participants will need to meet certain health criteria and agree to regular blood tests and other procedures to monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be willing to provide informed consent.
  • Must have a confirmed diagnosis of pancreatic cancer.
  • Cancer must have progressed after initial treatments like FOLFIRINOX or gemcitabine-based therapy.
  • Must be in good overall health with a performance status of 0 or 1.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Must have measurable cancer as defined by specific criteria.
  • Must be willing to undergo certain medical procedures as part of the study.
  • Must agree to long-term follow-up as part of the study requirements.
  • Must have adequate organ function as determined by specific blood tests.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Recent major surgery or radiation therapy.
  • Recent live vaccination.
  • Currently participating in another clinical trial.
  • History of severe allergic reactions to similar treatments.
  • Active infections or autoimmune diseases requiring treatment.
  • Uncontrolled HIV, Hepatitis B, or Hepatitis C infections.
  • History of other cancers unless treated and in remission for at least 2 years.
  • Significant heart disease or other serious medical conditions.
  • History of organ transplant or severe psychiatric disorders.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.