IL-18 Armored STEAP1 CAR T Cells for the Treatment of Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07803653
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Castration-Resistant Prostate Adenocarcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FH-STEAP1 IL-18 CAR T cells — BIOLOGICAL
    Given FH-STEAP1 IL-18 CAR T cells IV
  • Antiandrogen Therapy — DRUG
    Receive standard of care androgen deprivation therapy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Scan — PROCEDURE
    Undergo nuclear medicine bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Cyclophosphamide — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Fludarabine — DRUG
    Given IV
  • Leukapheresis — PROCEDURE
    Undergo leukapheresis
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy

Study Details

This phase I trial tests the safety, side effects, best dose and how well giving IL-18 armored STEAP1 CAR T cells after lymphodepleting chemotherapy (with cyclophosphamide and fludarabine) works for the treatment of castration resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Giving chemotherapy, with cyclophosphamide and fludarabine, prior to CAR T cells helps kill cancer cells in the body and prepare the body to receive the CAR T cells. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer 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 cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving IL-18 armored STEAP1 CAR T cells after lymphodepleting chemotherapy may be safe, tolerable and/or effective in treating patients with metastatic castration resistant prostate cancer.

Key Dates

First listed
Sep 4, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2044

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemotherapy, FH-STEAP1 IL-18 CAR T cells)
    Patients undergo leukapheresis. Patients receive cyclophosphamide intravenously (IV) and fludarabine IV on days -5 to -3. Patients receive FH-STEAP1 IL-18 CAR T cell IV on day 0. Patients may continue to receive androgen deprivation therapy per standard of care, throughout the study. Patients undergo nuclear medicine bone scan, CT scan, MRI and/or PET scan, tumor biopsy and blood sample collection throughout the study. Patients may also undergo MUGA scan or echocardiography during screening.

Primary Outcome Measure

Treatment-related unexpected grade 3 or higher toxicity [ Time Frame: Up to 28 days post infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Fred Hutch Intake
[email protected]
206-606-1024
Rosa Nadal Rios, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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