Cell Therapy (STEAP1 CART) with Enzalutamide for Treating Advanced Prostate Cancer

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT06236139

Provider View

This clinical trial is exploring a new treatment combining cell therapy (STEAP1 CART) with the drug enzalutamide for men with prostate cancer that has spread and continues to grow despite treatments to lower male hormones.

Patient Parameters

Program Overview

This study is testing a new approach to treat prostate cancer that has spread and is resistant to hormone-blocking treatments. The trial combines a special cell therapy called STEAP1 CART with enzalutamide, a drug that blocks male hormones. The cell therapy involves modifying a patient's immune cells to better target and attack prostate cancer cells. Enzalutamide helps stop the growth of cancer by blocking the effects of male hormones. The goal is to see if this combination can more effectively kill cancer cells in patients with advanced prostate cancer.

Description

In this study, patients will first undergo a procedure called leukapheresis to collect their immune cells. They will then receive chemotherapy drugs cyclophosphamide and fludarabine through an IV for three days. On the fourth day, they will receive the modified STEAP1 CART cells through an IV. Patients may also start taking enzalutamide by mouth on the same day and continue daily unless the cancer progresses or side effects become too severe.

Throughout the study, patients will have tumor biopsies and various scans, such as bone scans, CT, MRI, or PET scans, to monitor the cancer. They may also have heart function tests if needed.

After completing the treatment, patients will have follow-up visits at 2, 3, 4, 5, 6, 9, and 12 months, then every 6 months up to 5 years, and yearly up to 15 years.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer.
  • Cancer that can be measured by scans or blood tests.
  • Cancer that has progressed despite hormone-blocking treatments.
  • Have tried at least two different treatments for metastatic prostate cancer, including at least one advanced hormone therapy.
  • Low testosterone levels, with or without ongoing hormone therapy.
  • Aged 18 or older.
  • Able to understand and sign a consent form.
  • Willing to use effective birth control during and after the study.
  • Good overall health with a performance status of 0 or 1.
  • May receive radiation for symptom relief, except two weeks before cell collection.
  • Adequate kidney and liver function based on specific blood tests.
  • Good lung function and oxygen levels.
  • Heart function tests required for participants aged 60 or older.
  • Sufficient blood cell counts.

Exclusion Criteria

  • Planning to have children during or shortly after the study.
  • Active autoimmune disease requiring treatment.
  • Taking high doses of steroids.
  • Using other experimental cancer treatments.
  • Uncontrolled infections or illnesses.
  • Untreated or unstable brain metastases.
  • Ongoing treatment for serious side effects from previous immunotherapy.
  • Significant neurological diseases unless approved by the study doctor.
  • Any other medical or personal issues that could interfere with the study.
  • Known allergies to study treatments.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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