Cell Therapy + Enzalutamide for Prostate Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot use other investigational anti-cancer agents during the trial, except for androgen deprivation therapy.
What data supports the effectiveness of the treatment Cell Therapy + Enzalutamide for Prostate Cancer?
Is the combination of cell therapy and Enzalutamide safe for prostate cancer treatment?
The combination of Enzalutamide with other treatments, like Entinostat, has shown a promising safety profile in early studies for prostate cancer. Additionally, STEAP1-targeted CAR T cell therapies have demonstrated safety in preclinical models, suggesting they may be safe for further development in humans.12567
What makes the STEAP1 CART treatment for prostate cancer unique?
The STEAP1 CART treatment is unique because it involves using genetically modified immune cells (CAR T-cells) to specifically target and attack prostate cancer cells, which is different from traditional treatments like enzalutamide that focus on blocking androgen receptors to slow cancer growth.7891011
What is the purpose of this trial?
This phase I/II trial tests the safety and effectiveness of cell therapy (STEAP1 CART) with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production (castration-resistant) and that has spread from where it first started (the prostate) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer deaths in men. Localized prostate cancer is often curable and even metastatic disease may respond to treatment for a few years. Despite multiple therapies, including hormone therapy and chemotherapy, metastatic castration-resistant prostate cancer (mCRPC) still remains an incurable disease. Recently, adoptive cellular immunotherapies have been developed to transfer immunogenic cells to the patient to produce an anti-tumor response. Chimeric antigen receptor T (CART)-cell therapy is a type of treatment in which a patient's T-cells (a type of immune cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Prostate stem cell antigen and prostate specific membrane antigen CAR T cell therapies have been shown to be safe and effective, but objective tumor responses remain rare. STEAP1 is an antigen that promotes cancer growth and spread and is found to be broadly expressed in mCRPC tissues. STEAP1 CART is CAR T cells that have been engineered with a STEAP1 antigen to better target prostate tumor cells. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving STEAP1 CART with enzalutamide may kill more tumor cells in patients with mCRPC.
Research Team
Rosa Nadal Rios, MD, PhD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
This trial is for men with metastatic castration-resistant prostate cancer, which has spread beyond the prostate and resists treatment to lower male hormones. Participants must have tried hormone therapy and chemotherapy without success.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and Pre-treatment
Patients undergo leukapheresis and receive cyclophosphamide and fludarabine intravenously on days -5, -4, and -3
Treatment
Patients receive STEAP1 CART infusion on day 0 and may receive enzalutamide orally starting on day 0
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enzalutamide
- STEAP1 CART
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
PromiCell Therapeutics, Inc.
Collaborator