Safety Study of BPX-201 Dendritic Cell Vaccine Plus AP1903 in Metastatic Castrate Resistent Prostate Cancer

Exclusion Criteria

• •1. Prior chemotherapy for prostate cancer, with the exception of neo-adjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system.
• •2. Prior sipuleucel-T treatment or investigational immunotherapy.
• •3. Prostate cancer pain requiring regularly scheduled narcotics.
• •4. Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable). Systemic corticosteroids must be discontinued for at least 4 weeks prior to first treatment.
• •5. Clinically active autoimmune disease.
• •6. Diagnosis of prostate cancer with neuroendocrine differentiation
• •7. Known presence of central nervous system metastases, pleural effusions or ascites
• •8. Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves.
• •9. Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association Class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months).
• •10. Concurrent or prior malignancy except for the following:
• •* Adequately treated basal or squamous cell skin cancer
• •* Adequately treated stage I or II cancer from which the patient is currently in complete remission
• •* Any other cancer from which the patient has been disease-free for 5 years
• •11. Known HIV or other history of immunodeficiency disorder.
• •12. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness.
• •13. Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of BPX-201 and AP1903 hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
• •14. Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 1 month before BPX-201