OncoMatch/Clinical Trials/NCT06236139
Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Is NCT06236139 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Anti-STEAP1 CAR T-cells and Cyclophosphamide for castration-resistant prostate carcinoma.
Treatment: Anti-STEAP1 CAR T-cells · Cyclophosphamide · Enzalutamide · Fludarabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Allowed: BRCA1 any tested
All available targeted therapies for which they are eligible in the metastatic setting (e.g., PARP inhibitors for BRCA 1/2...)
Allowed: BRCA2 any tested
All available targeted therapies for which they are eligible in the metastatic setting (e.g., PARP inhibitors for BRCA 1/2...)
Allowed: MSH2 microsatellite instability-high
immune checkpoint inhibitor for MSI-H
Allowed: MSH6 microsatellite instability-high
immune checkpoint inhibitor for MSI-H
Allowed: MLH1 microsatellite instability-high
immune checkpoint inhibitor for MSI-H
Allowed: PMS2 microsatellite instability-high
immune checkpoint inhibitor for MSI-H
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen receptor signaling inhibitor (abiraterone, darolutamide, apalutamide, enzalutamide) — metastatic
at least one being a second generation androgen receptor signaling inhibitor (e.g., abiraterone, darolutamide, apalutamide, or enzalutamide)
Must have received: FDA-approved therapy — metastatic
At least two Food and Drug Administration (FDA)-approved therapies with at least one being a second generation androgen receptor signaling inhibitor
Must have received: targeted therapy (PARP inhibitor, immune checkpoint inhibitor) — metastatic
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)
Lab requirements
Blood counts
ANC > 1500 cells/mm^3; Hemoglobin > 9 g/dL; Platelets > 100,000 per mm^3
Kidney function
Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance > 50 mL/min and not dialysis dependent
Liver function
Total bilirubin ≤ 1.5 x ULN (Gilbert syndrome: Bili > 3 mg/dL but no other evidence of hepatic dysfunction); AST and ALT < 5 x ULN
Cardiac function
Participants ≥ 60 years: LVEF ≥ 35% by echocardiogram or MUGA scan within 1 year prior to lymphodepletion chemotherapy; cardiac evaluation for others at physician discretion
Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance > 50 mL/min 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; AST and ALT < 5 x ULN; ANC > 1500 cells/ mm^3; Hemoglobin > 9 g/dL; Platelets > 100,000 per mm^3; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify