Actively Recruiting
Phase 1/2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Men With Metastatic Castration-Resistant Prostate Cancer
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-17
48
Participants Needed
1
Research Sites
N/A
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
Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that continues to grow despite treatments that lower male hormones and has spread to other parts of the body. This trial evaluates the safety and effectiveness of a new cell therapy called STEAP1 CART combined with enzalutamide, an androgen receptor blocker. The study aims to find out if this combination can better target tumor cells and improve treatment outcomes in this difficult-to-treat cancer. Participants first undergo leukapheresis to collect their immune cells. Before receiving the STEAP1 CART cell infusion, they get chemotherapy with cyclophosphamide and fludarabine on days -5, -4, and -3. On day 0, they receive the STEAP1 CART infusion along with enzalutamide taken by mouth daily if tolerated and without disease progression. The study also includes tumor biopsies at baseline, day 14, and optionally at progression. Imaging tests like bone scans, CT, MRI, or PET scans, along with blood tests and heart function scans, are performed throughout the study. After treatment, patients are followed regularly up to 15 years to monitor effects and safety. During the study, participants will have multiple assessments including tumor biopsies, blood collections, and various imaging scans to track cancer response and any side effects. The main outcomes measured include adverse events within 28 days after infusion, tumor response over one year, and prostate-specific antigen (PSA) changes. Secondary measures include survival and disease progression up to one year post-infusion. Long-term follow-up occurs at scheduled visits from 2 months up to 15 years after treatment to ensure ongoing monitoring of health and treatment effects.
CONDITIONS
Brief 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 criteria or bone metastases with PSA 1 ng/mL
- Progressed after becoming castration-resistant with at least 2 rising PSA levels or new bone lesions
- Received at least two metastatic prostate cancer treatments including one second generation androgen receptor inhibitor
- Castrate testosterone levels (< 50 ng/dL) with or without androgen deprivation therapy
- Male, age 18 years or older
- Able to provide written informed consent
- Fertile males and partners agree to effective contraception before, during, and 4 months after STEAP1 CART infusion
- ECOG performance status 0 or 1
- Allowed palliative radiation except 2 weeks before leukapheresis
- Kidney function within limits: creatinine �b1.5 x ULN or clearance > 50 mL/min
- Liver function within limits: bilirubin �b1.5 x ULN or Gilbert syndrome without dysfunction, AST and ALT < 5 x ULN
- Grade 1 or less dyspnea with oxygen saturation �b92% on room air
- If pulmonary tests done, FEV1 �b5% and DLCO �b40% predicted
- Age 60 or older must have left ventricular ejection fraction �b35% within 1 year
- Absolute neutrophil count > 1500 cells/mm3
- Hemoglobin > 9 g/dL
- Platelets > 100,000 per mm3
You will not qualify if you...
- Expecting to conceive or father children during trial and 4 months after T cell infusion
- Active autoimmune disease needing immunosuppressive therapy unless approved case by case
- Taking corticosteroids > 15 mg prednisone daily except pulsed use
- Using other investigational anti-cancer agents except androgen deprivation therapy
- Active uncontrolled infection except controlled HIV, hepatitis B or C
- Uncontrolled illnesses like symptomatic heart failure, unstable angina, or arrhythmia
- Untreated brain metastases; small treated brain metastases may be allowed
- Ongoing treatment for prior serious immune-related adverse events except hormone or low dose steroids
- Significant active neurologic disease unless approved
- Medical, social, or psychiatric issues 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month or until disease progression or unacceptable toxicity
Participants undergo leukapheresis followed by chemotherapy with cyclophosphamide and fludarabine intravenously on days -5, -4, and -3, then receive STEAP1 CART infusion on day 0. Participants may also take enzalutamide orally starting on day 0 once daily in the absence of disease progression or unacceptable toxicity. Tumor biopsies are performed at baseline and day 14, with optional biopsy at progression. Blood samples, NM bone scans, and CT, MRI, or PET scans are collected throughout treatment.
Multiple visits including leukapheresis, chemotherapy visits on days -5 to -3, infusion on day 0, and several visits for biopsies and imaging during treatment
Duration - Up to 15 years
After completion of study treatment, participants are followed for safety and disease status with visits at 2, 3, 4, 5, 6, 9, and 12 months, then every 6 months up to year 5, followed by yearly visits up to year 15.
Visits at 2, 3, 4, 5, 6, 9, and 12 months, then every 6 months up to year 5, then yearly visits thereafter
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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