Study on HER2 FPBMC Treatment for Patients with Metastatic Breast and Prostate Cancer

Sponsor: University of Virginia

Sponsor score: 0

ClinicalTrials ID:NCT07441889

Provider View

This clinical trial is testing a new treatment using modified white blood cells to target and attack cancer cells in patients with advanced breast or prostate cancer. Participants will receive a series of infusions to evaluate the safety and effectiveness of this approach.

Patient Parameters

Program Overview

The study aims to test the safety and effectiveness of a new treatment using modified white blood cells, called HER2 FPBMC, in patients with metastatic breast or prostate cancer. Participants will receive five weekly infusions of these modified cells, followed by four more infusions every other week. The treatment involves collecting white blood cells from the patient, modifying them to better target cancer cells, and then re-infusing them into the patient. Researchers will monitor the patients' immune response and cancer status throughout the study.

Description

In this study, patients with advanced breast or prostate cancer will undergo a procedure to collect their white blood cells. These cells will be modified in the lab to help them recognize and attack cancer cells more effectively. The modified cells, known as HER2 FPBMC, will be infused back into the patient over several weeks. The study will monitor the safety and effectiveness of this treatment by checking the patients' immune response and cancer status regularly. Participants will have their white blood cells collected again after the initial set of infusions to continue monitoring their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate in the study.
  • Willingness to follow all study procedures and be available for the study duration.
  • Age 18 years or older.
  • Expected to live at least 3 more months, as judged by the study doctor.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate organ function based on specific blood test results.
  • Must agree to follow lifestyle guidelines during the study.
  • Diagnosed with either metastatic prostate or breast cancer:
    • Prostate Cancer: Must have confirmed prostate cancer that has spread and progressed after previous treatments. Must have low testosterone levels and at least one visible metastatic lesion.
    • Breast Cancer: Must have confirmed invasive breast cancer that has spread and progressed after previous treatments. Must have at least one visible metastatic lesion.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Recent or past heart attack with ongoing heart issues.
  • Poor heart function or serious heart conditions.
  • Immune system deficiencies or on immunosuppressive therapy.
  • Serious wounds or recent major surgery.
  • Active liver disease or infections like HIV, Hepatitis B, or C.
  • High risk of bleeding or active infections.
  • Other serious medical conditions that could interfere with the study.
  • History of tuberculosis or recent live vaccine.
  • Recent treatment with investigational drugs.
  • Active second cancer requiring treatment, except for certain skin or cervical cancers.
  • Active autoimmune diseases requiring treatment in the past two years.
  • Conditions that could affect study results or participation.

Additional Exclusion Criteria for Prostate Cancer:

  • Specific types of prostate cancer or genetic mutations with available treatments.

Additional Exclusion Criteria for Breast Cancer:

  • Genetic mutations with available treatments or severe complications from cancer spread.

Locations

FACILITYZIPCITYSTATE
University of Virginia22903CharlottesvilleVirginia

Get This Program In Your Inbox

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