HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)

Exclusion Criteria

• •1. Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation
• •2. History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week
• •3. Inadequate cardiac function, as defined as any of the following:
• •* Uncontrolled angina or severe ventricular arrhythmias
• •* Clinically significant pericardial disease
• •* History of myocardial infarction (MI) in the last year before registration
• •* Class 3 or higher New York Heart Association Congestive Heart Failure
• •4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• •5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration
• •6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
• •7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus.
• •8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
• •9. Has an active infection requiring systemic therapy
• •10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy
• •11. Has a known history of active TB (Bacillus Tuberculosis)
• •12. Has received a live vaccine within 30 days of study registration.
• •13. Treatment with any investigational agent within 3 weeks prior to study registration
• •14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin
• •15. Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• •16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
• •17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant
• •1. Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions
• •2. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.
• •1. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.
• •2. Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary lymphangitis, or liver involvement \> 50%.