Actively Recruiting
Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-17
48
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
P
PromiCell Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tissue confirmation of prostate adenocarcinoma
- Measurable disease by RECIST 1.1 or bone-only metastases with measurable PSA (\u2265 1 ng/mL)
- Progression after becoming castration-resistant defined by at least 2 rising PSA levels, RECIST progression, or 2+ new bone lesions
- Received at least two lines of treatment including at least one second generation androgen receptor signaling inhibitor
- Received all available targeted therapies for which eligible in metastatic setting
- Castrate testosterone levels (< 50 ng/dL) with or without androgen deprivation therapy
- 18 years or older at enrollment
- Able to understand and provide written informed consent
- Fertile males and partners must use effective contraception before, during, and 4 months after infusion
- ECOG performance status 0 or 1
- Allowed palliative radiation except 2 weeks before leukapheresis
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 50 mL/min, not dialysis dependent
- Total bilirubin ≤ 1.5 x ULN or Gilbert syndrome without hepatic dysfunction
- AST and ALT < 5 x ULN
- Grade ≤ 1 dyspnea and oxygen saturation ≥ 92% on room air
- If pulmonary function tests done, FEV1 ≥ 50% predicted and DLCO ≥ 40% predicted
- Participants ≥ 60 years require left ventricular ejection fraction ≥ 35% within 1 year prior
- Absolute neutrophil count > 1500 cells/mm3
- Hemoglobin > 9 g/dL
- Platelets > 100,000/mm3
You will not qualify if you...
- Expecting to conceive or father children through 4 months after infusion
- Active autoimmune disease requiring immunosuppressive therapy (case-by-case exceptions)
- Corticosteroid therapy > 15 mg prednisone daily (except pulsed use for disease control)
- Use of other investigational anti-cancer agents except androgen deprivation therapy
- Active uncontrolled infection not controlled by therapy
- Uncontrolled illness including symptomatic heart failure or unstable angina
- Untreated brain metastases (small asymptomatic or treated controlled may be considered)
- Ongoing treatment for prior serious immune-related adverse events
- Significant active neurologic disease unless approved
- Medical, social, or psychiatric factors interfering with study compliance
- Known allergies to any study treatment components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
Fred Hutch Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here