Combined AlloStim+Anti-PD-L1 in 4L MSS Metastatic Colorectal Cancer

Exclusion Criteria

• •1. High frequency microsatellite instability (MSI-H) or deficient mismatched repair dMMR
• •2. Bowel obstruction or high risk for obstruction if tumors become inflamed
• •3. Moderate or severe ascites requiring medical intervention
• •4. Clinical evidence of brain metastasis or leptomeningeal involvement
• •5. Widespread peritoneal carcinomatous (e.g. CT scan shows innumerable lesions visible and/or abnormal thickening of greater omentum) that increases risk of a major morbidity (e.g. bowel obstruction) in the opinion of the Investigator
• •6. COPD
• •7. Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment; or, oxygen saturation \<92% on room air
• •8. Any of the following mood disorders: active major depressive episode, recent history of suicidal attempt or ideation
• •9. Prior allogeneic bone marrow/stem cell or solid organ transplant
• •10. Chronic use (\> 2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to \> 5 mg/day of prednisone) planned or anticipated during the study before the end of the Safety Evaluation Period (28 days after the last dose of IP)
• •* Topical corticosteroids are permitted
• •11. Prior diagnosis of an active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis)
• •* Well controlled Type I diabetes allowed (HbA1c \< 8.5%)
• •12. Prior experimental immunotherapy
• •13. History of blood transfusion reactions
• •14. Progressive viral or bacterial infection
• •o All infections must be resolved and the subject must remain afebrile for seven days without antibiotics prior to being placed on study
• •15. Cardiac disease of symptomatic nature
• •16. History of HIV positivity or AIDS
• •17. History of severe hypersensitivity to monoclonal antibody drugs
• •18. Psychiatric or addictive disorders or other condition that, in the opinion of the Investigator, would preclude study participation.
• •19. Subjects that lack ability to provide consent for themselves
• •20. Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, superficial Ta, Tis, T1 bladder cancer, or papillary carcinoma of thyroid) or concurrent cancer histologically different than colorectal adenocarcinoma