Study of INKmune in Patients With mCRPC (CaRe Prostate)

Exclusion Criteria

• •The participant may not enter the study if ANY of the following apply:
• •1. Diagnosis of small cell/neuroendocrine prostate cancer. Immunohistochemical staining for neuroendocrine markers (e.g., chromogranin A, neuron-specific enolase, and synaptophysin) is not sufficient to establish a small cell/neuroendocrine histology; morphologic features that are characteristic of small cell/neuroendocrine prostate cancer are required to confirm the presence of small cell/neuroendocrine prostate cancer.
• •2. History of concurrent malignant cancer within previous 3 years, with the exception of in situ carcinomas and non-melanoma skin cancer. If diagnosis or treatment for other cancers have occurred in the last 3 years, further discussion needed.
• •3. Uncontrolled autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis. Autoimmune conditions that are well-controlled in the opinion of the investigator must first be discussed with the Sponsor prior to enrollment.
• •4. A requirement for daily systemic corticosteroids for any reason; or other immunosuppressive or immunomodulatory agents. Topical, nasal, modified-release oral, and/or physiologic corticosteroids may be permitted following discussion with the Sponsor.
• •5. Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease.
• •6. Patients with a current or recent history, as determined by the Investigator, of clinically significant, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastroenterological, or neurological disease.
• •7. Cytotoxic chemotherapy within three weeks prior to start of study treatment (Day 1).
• •8. Radiation therapy within two weeks prior to start of study treatment (Day 1).
• •9. Patients may not have received a previous NK based therapy.
• •10. Evidence of central nervous system (CNS) metastatic disease at screening.
• •11. Patients with an active infection requiring antibiotic treatment within seven days of starting study treatment (Day 1).
• •12. Administration of live attenuated vaccines within eight weeks of start of study treatment (Day 1) and throughout the study.
• •13. Any other medical condition that in the opinion of the Investigator may interfere with a subject's participation in, or compliance with, the study
• •14. Participation in a therapeutic research study or receipt of an investigational drug within 4 weeks of start of treatment (Day 1) or 5 half-lives, whichever occurs first.
• •15. Expected survival of less than six months
• •16. At the time of consent, unable to comply with study procedures and assessments.