MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer

Exclusion Criteria

• •1. The presence of brain metastases, pleural effusions or ascites
• •2. Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%), or spinal cord compression
• •3. A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the patient must be disease-free at the time of registration. Patients with a history of stage I or II other cancers must have been adequately treated and been disease-free for 3 years at the time of registration.
• •4. More than 1 prior chemotherapy, biologic or combination treatment regimen (including vitamin D analogues) for CRPC
• •5. Any treatment with radiopharmaceuticals, e.g. Strontium-89 and Samarium-153
• •7. Initiation of bisphosphonate therapy within 28 days prior to registration. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted.
• •8. A requirement for systemic steroid or other immunosuppressive therapy for any reason.
• •9. Treatment with any of the following medications or interventions \< 28 days prior to Screening
• •10. Treatment with any investigational vaccine within 2 years prior to Screening, or treatment with any other investigational product within 28 days prior to Screening
• •11. Any antibiotic therapy or infection within 1 week prior to Screening, including unexplained fever (temperature ≥ 100.5F or 38.1C)
• •12. History of autoimmune disease
• •13. Serious ongoing chronic or acute illness
• •14. Any medical intervention or other condition which, in the opinion of the Principal Investigator and/or the Bellicum Medical Monitor, could compromise adherence with study requirements
• •Other Criteria Apply however are not listed