Not yet recruitingPhase 1

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

Phase 1 Dose-Escalation and Expansion Study of IL-18 Armored STEAP1 CAR T in Participants With mCRPC

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Blood draws, MRI scans, CT scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety, side effects, best dose, and possible benefits of IL-18 armored STEAP1 CAR T cells after chemotherapy. These are a patient's own immune cells, changed in a lab to attack cancer. It is for adults with prostate cancer that has spread and keeps growing despite very low testosterone levels.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, and able to understand the study and give written consent.
  • Have prostate adenocarcinoma confirmed by a tissue test. Cancer must be measurable on scans, or have spread only to bones with a PSA blood test level of at least 1 ng/mL.
  • Have prostate cancer that has spread and resists treatment that lowers testosterone. After this resistance began, at least one whole-body treatment must have stopped helping, kept the cancer stable, or caused side effects you could not tolerate.
  • Have received at least two approved treatments for cancer that has spread, including a newer drug that blocks male hormone signals. Have received targeted drugs you qualify for, unless they were unsafe, unavailable, or you chose not to take them.
  • Have testosterone below 50 ng/dL, with or without hormone-lowering treatment.
  • Be fully active or able to do light work. Meet the study's blood count, kidney, liver, and breathing requirements; people age 60 or older also need a heart pumping test.
  • If able to father a child, you and your female partner must use effective birth control before, during, and for at least 4 months after the cell treatment.
  • Radiation to ease symptoms is allowed, except in the 2 weeks before blood cells are collected.

Who can't join

  • Plan to father a child during the study or within 4 months after the cell treatment.
  • Need urgent treatment because a tumor is pressing on the spinal cord or other body parts, or have cancer that has spread to the brain.
  • Have an active disease where the immune system attacks the body and need ongoing immune-suppressing drugs, or take more than 10 mg of prednisone daily or a similar steroid dose. Some exceptions apply.
  • Have an uncontrolled illness or infection. Controlled HIV or hepatitis may be allowed; a recent stroke, mini-stroke, heart artery problem, or abnormal heartbeat needs specialist approval.
  • Use another experimental cancer drug, except hormone-lowering therapy, or need ongoing treatment for a past serious immune reaction to immune therapy. Some exceptions apply.
  • Have another cancer that needed whole-body treatment in the past 4 years or has not fully gone away. Successfully treated skin cancers that have not spread may be allowed.
  • Have a known allergy to any study treatment ingredient, or a medical, mental health, or social issue that could make participation unsafe or difficult.
  • Have no suitable standard treatment available to control the cancer if it worsens while you are being screened or your CAR T cells are being made.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. * Targeted therapies for which they are eligible in the metastatic setting unless the patient has contraindications to receiving those medications, the agents are not available to the patient or the patient declines to receive these drugs due to personal preference * 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 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 FH-STEAP1 IL-18 CAR T cell infusion * 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * 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 at 1 second (FEVI) ≥ 50% of predicted and carbon monoxide diffusing capability (DLCO) (adjusted for lung volume) of ≥ 40% of predicted will be eligible * All 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 an echocardiogram or MUGA scan, and left ejection fraction must be ≥ 45% * Absolute neutrophil count (ANC) \> 1500 cells/ mm\^3 * Hemoglobin ≥ 9g 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 * Patients that require immediate therapy due to mass effect or spinal cord compression * Active autoimmune disease: Participants with active autoimmune disease requiring chronic immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by principal investigator (PI) * Corticosteroid therapy at a dose equivalent of \> 10 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 * Uncontrolled concurrent illness: Participants may not have uncontrolled respiratory, endocrine, renal, gastrointestinal, genitourinary or systemic infection. There are exceptions to this criterion: * 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; * Patients who have recent history of cerebrovascular accident, transient ischemic attack should be cleared by the neurology service before enrolling this study * Patients who have recent history of coronary artery disease or cardiac arrhythmia should be cleared by the cardiology service before enrolling this study. Case by case exemptions are possible with approval by PI * Participants with brain metastasis * 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 \> 10 mg prednisone (or equivalent) per day, unless otherwise approved by PI * Patients with a second malignancy in addition to their prostate cancer are not eligible if the second malignancy has required systemic treatment within the past 4 years or is not in complete remission. There are exceptions to this criterion: successfully treated non-metastatic basal cell and squamous cell skin carcinoma * 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 * Participants who do not have a reasonable standard-of-care bridging therapy option available, as determined by the treating medical oncologist, to maintain disease control should clinically significant disease progression or worsening symptoms occur during the screening and T-cell manufacturing period

Study sites (1)

WA