Cell Therapy (STEAP1 CART) with Enzalutamide for Metastatic Prostate Cancer
This study is looking at a new treatment for metastatic castration-resistant prostate cancer, which is prostate cancer that has spread and is no longer responding to standard hormone therapy. The treatment combines a cell therapy called Anti-STEAP1 CAR T-cells with an existing medication, enzalutamide. Researchers want to see how safe this combination is and how well it works to shrink tumors or stop the cancer from growing. You might be able to join if you are a man aged 18 or older with this type of prostate cancer that has continued to grow despite previous treatments. The study will measure side effects and how many people respond to the treatment. The current status of this study is unclear, and it plans to enroll 48 participants.
- Study design
- This is a dose escalation study followed by a dose expansion study, meaning the dose of STEAP1 CART will be gradually increased to find the safest and most effective amount. The study plans to enroll 48 participants.
- What's involved
- You would undergo leukapheresis (a procedure to collect your white blood cells), receive chemotherapy, and then the STEAP1 CART cell therapy. You would also take enzalutamide daily and have tumor biopsies, blood draws, bone scans, and CT scans throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed for up to 15 years, with more frequent visits in the first year and then yearly visits.
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NCT06236139
Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~48 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Anti-STEAP1 CAR T-cellsBiopsy ProcedureBiospecimen CollectionBone ScanComputed TomographyCyclophosphamide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 3 or higher treatment related unexpected adverse events (AEs) (Phase I)
Measured over Up to 28 days post infusion
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Rosa Nadal Rios, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Tissue confirmation of prostate adenocarcinoma
Measurable disease by RECIST 1.1 criteria or bone only metastases with measurable PSA ( ≥ 1 ng/mL)
Must have progressed (at least 2 rising PSA levels with at least a 1-week interval and a minimum PSA of 1.0 ng/mL, progression per RECIST 1.1, or 2 or more new bone lesions by bone scan), after becoming castration-resistant
Have received the following for metastatic prostate cancer:
At least two lines of treatment
At least two Food and Drug Administration (FDA)-approved therapies with at least one being a second generation androgen receptor signaling inhibitor (e.g., abiraterone, darolutamide, apalutamide, or enzalutamide)
All available targeted therapies for which they are eligible in the metastatic setting (e.g., PARP inhibitors for BRCA 1/2 and immune checkpoint inhibitor for MSI-H or TMB-H ≥ 10 mut/Mb)
Castrate levels of testosterone (\< 50 ng/dL) with or without the use of androgen deprivation therapy (ADT)
18 years or older at the time of enrollment
Capable of understanding and providing a written informed consent
Fertile male participants and their female partners must be willing to use an effective contraceptive method before, during, and for at least 4 months after the STEAP1 CART cell infusion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants will be permitted to receive radiation therapy for palliative purposes throughout the study period, except during the 2-week period prior to undergoing leukapheresis
Serum creatinine =\< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \> 50 mL/min as calculated using the Cockcroft-Gault formula and not dialysis dependent
Total bilirubin ≤ 1.5 x ULN. Participants with suspected Gilbert syndrome may be included if Total bilirubin (Bili) \> 3 mg/dL but no other evidence of hepatic dysfunction
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN
≤ grade 1 dyspnea and oxygen saturation (SaO2) ≥ 92% on ambient air
If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in 1 second (FEVI) \>= 50% of predicted and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) of \>= 40% of predicted will be eligible
Participants \>= 60 years of age are required to have left ventricular ejection fraction (LVEF) evaluation performed within 1 year prior to lymphodepletion chemotherapy. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be \>= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician
Absolute neutrophil count (ANC) \> 1500 cells/ mm\^3
Hemoglobin \>= 9 g/dL
Platelets \> 100,000 per mm\^3
Exclusion
Expecting to conceive or father children for the duration of the trial through 4 months after T cell infusion
Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by principal investigator (PI)
Corticosteroid therapy at a dose equivalent of \>15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable
Concurrent use of other investigational anti-cancer agents except for ADT
Active uncontrolled infection: human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \> 500 cells/mm\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication
Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit compliance with study requirements
Participants with brain metastasis
Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of \> 15 mg prednisone (or equivalent) per day, unless otherwise approved by PI
Significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, unless approved by PI. Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable
Other medical, social, or psychiatric factor that interferes with medical appropriateness and/or ability to comply with study, as determined by the PI
Known allergic reactions to any of the components of study treatments
Participants with no bridging therapy options according to the treating medical oncologist. The specific bridging treatment plan must be documented in the Electronic Medical Record (EMR) by the treating medical oncologist within 2 weeks of signing informed consent
What this trial measures
- Incidence of grade 3 or higher treatment related unexpected adverse events (AEs) (Phase I)Up to 28 days post infusion
Toxicity will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
- Incidence of AEs (Phase II)Up to 28 days post infusion
Toxicity will be graded according to NCI CTCAE v 5.0.
- Response (Phase II)Up to 1 year post infusion
Response will be defined as best overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and/or Prostate Cancer Working Group 3 (PCWG3) criteria.