Engineered immune cells take on Hard-to-Treat prostate cancer
NCT ID NCT06236139
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests whether a new cell therapy called STEAP1 CAR T, given together with the hormone drug enzalutamide, is safe and effective for men with metastatic castration-resistant prostate cancer (mCRPC). The therapy uses a patient's own immune cells, modified in the lab to better target prostate cancer cells. The trial will enroll 48 participants and monitor side effects, tumor shrinkage, and PSA levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STEAP1 CAR T-cells (a type of cell therapy) and enzalutamide (a hormone-blocking drug)
- What this could lead to
- If successful, this combination could offer a new treatment option for men with advanced prostate cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial with only 48 participants, so results may not apply broadly. CAR T-cell therapy can cause serious side effects, and it is unknown if the combination will work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered immune cells take down advanced prostate cancer?
- Can a Chemo-Targeted drug combo outsmart Treatment-Resistant prostate cancer?
- Can a new drug tame metastatic prostate cancer? a phase 1 trial aims to find out
- Mapping radiation dose in real time: a smarter way to treat prostate cancer?
- Can a tracer that hunts unstable iron light up hidden tumors?
- Can a three-drug cocktail outsmart resistant prostate cancer?