Fred Hutchinson Cancer Center
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.
OUTLINE: 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, computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan, tumor biopsy and blood sample collection throughout the study. Patients may also undergo multigated acquisition (MUGA) scan or echocardiography duri…
Inclusion Criteria: * Documented, histologically confirmed adenocarcinoma of the prostate * Measurable disease by RECIST 1.1 criteria or bone only metastases with measurable PSA (≥ 1ng/mL) * Must have mCRPC with progressive disease (PD), stable disease (SD), lack of clinical benefit or intolerance to ≥ 1 line of systemic therapy, after becoming castration resistant * Have received the following for metastatic prostate cancer: * At least two lines of Food and Drug Administration (FDA)-approved therapies with at least one being a second-generation androgen receptor signaling inhibitor. * T…
Given FH-STEAP1 IL-18 CAR T cells IV
Receive standard of care androgen deprivation therapy
Undergo blood sample collection
Undergo nuclear medicine bone scan
Undergo CT scan
Given IV
Undergo echocardiography
Given IV
Undergo leukapheresis
Undergo MRI
Undergo MUGA scan
Undergo PET scan
Undergo tumor biopsy