NCT06236139

Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting now Phase 1, PHASE2 Last updated 17 February 2026

What this trial tests

Phase 1, PHASE2 trial testing Anti-STEAP1 CAR T-cells in Castration-Resistant Prostate Carcinoma in 48 participants. Currently enrolling.

Timeline

26 November 2024

Primary endpoint
30 March 2027

30 March 2027

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	26 November 2024
Primary completion	30 March 2027
Estimated completion	30 March 2027
Sites	1 location across United States

Drugs / interventions tested

• Anti-STEAP1 CAR T-cells
• Biopsy
• Biospecimen Collection
• Bone Scan — full drug profile →
• Computed Tomography
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Echocardiography
• Enzalutamide (enzalutamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Leukapheresis — full drug profile →
• Magnetic Resonance Imaging
• Multigated Acquisition Scan
• Positron Emission Tomography

Conditions studied

• Castration-Resistant Prostate Carcinoma — all drugs for Castration-Resistant Prostate Carcinoma →
• Metastatic Prostate Adenocarcinoma — all drugs for Metastatic Prostate Adenocarcinoma →
• Stage IVB Prostate Cancer AJCC v8 — all drugs for Stage IVB Prostate Cancer AJCC v8 →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

18 and older, male only, with Castration-Resistant Prostate Carcinoma or Metastatic Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Overcoming drug resistance in castrate-resistant prostate cancer: current mechanisms and emerging therapeutic approaches.
   Khorasanchi A, Hong F, Yang Y, Singer EA, et al · · 2025 · cited 12× · PMID 40051495 · DOI 10.20517/cdr.2024.173
2. The application of emerging immunotherapy in the treatment of prostate cancer: progress, dilemma and promise.
   Che J, Liu Y, Liu Y, Song J, et al · · 2025 · cited 6× · PMID 40145100 · DOI 10.3389/fimmu.2025.1544882
3. Developmental Therapeutics in Metastatic Prostate Cancer: New Targets and New Strategies.
   Zhang J, Chadha JS. · · 2024 · cited 6× · PMID 39272956 · DOI 10.3390/cancers16173098
4. Collagen-binding IL-12-armoured STEAP1 CAR-T cells reduce toxicity and treat prostate cancer in mouse models.
   Sasaki K, Bhatia V, Asano Y, Bakhtiari J, et al · · 2026 · cited 5× · PMID 41125870 · DOI 10.1038/s41551-025-01508-3
5. Novel Therapeutic Strategies for Metastatic Prostate Cancer Care.
   Cimadamore A, Boixareu C, Sharp A, Beltran H, et al · · 2025 · cited 4× · PMID 40685286 · DOI 10.1016/j.eururo.2025.06.013
6. New frontiers in prostate cancer treatment from systemic therapy to targeted therapy.
   Nouruzi S, Kobelev M, Tabrizian N, Gleave M, et al · · 2025 · cited 3× · PMID 40759791 · DOI 10.1038/s44321-025-00282-8
7. The Role of STEAP1 in Prostate Cancer: Implications for Diagnosis and Therapeutic Strategies.
   Zhang L, Ren X, An R, Song H, et al · · 2025 · cited 3× · PMID 40299363 · DOI 10.3390/biomedicines13040794
8. Exploring STEAP1 Expression in Prostate Cancer Cells in Response to Androgen Deprivation and in Small Extracellular Vesicles.
   Bizzaro CL, Bach CA, Santos RA, Verrillo CE, et al · · 2025 · cited 3× · PMID 40287951 · DOI 10.1158/1541-7786.mcr-24-0903