Search / Trial NCT06236139

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

Launched by FRED HUTCHINSON CANCER CENTER · Jan 29, 2024

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Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Description

OUTLINE: This is a dose escalation study of STEAP1 CART in combination with enzalutamide followed by a dose expansion study. Patients undergo leukapheresis then receive cyclophosphamide intravenously (IV) and fludarabine IV on days -5, -4 and -3 and STEAP1 CART IV on day 0. Patients may receive enzalutamide orally (PO) on day 0 then once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy at baseline, day 14 and optionally at progression. Patients additionally undergo blood sample collection, nuclear medicine (NM) bone scan and co...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • * Tissue confirmation of prostate adenocarcinoma and STEAP1 expression. Confirmation of diagnosis must be or have been performed by internal pathology review of archival material at Fred Hutch/ University of Washington Medical Center (UWMC). Tissue will be stained by IHC to confirm STEAP1 expression
  • * 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, at any time, a CYP17 inhibitor or a second-generation antiandrogen therapy, and a taxane, or they must decline or be ineligible to receive these
  • * Castrate levels of testosterone (\< 50 ng/dL) with or without the use of androgen deprivation therapy
  • * 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 androgen deprivation therapy
  • * 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
  • * Untreated brain metastases: Participants with small asymptomatic brain metastases ( \< 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of principal investigator, so long as all other eligibility criteria are met
  • * 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

About Fred Hutchinson Cancer Center

Fred Hutchinson Cancer Center is a leading nonprofit research institution dedicated to the pursuit of innovative cancer treatments and prevention strategies. Established in Seattle, Washington, the center is renowned for its pioneering work in hematopoietic cell transplantation and its commitment to advancing cancer research through collaborative clinical trials. By integrating cutting-edge science with compassionate patient care, Fred Hutchinson Cancer Center aims to improve outcomes for patients while fostering a multidisciplinary approach to tackling complex cancer challenges. With a strong emphasis on translating research findings into clinical applications, the center is at the forefront of developing novel therapies that offer hope to patients worldwide.

Locations

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0