A Study of Type-1 Polarized Dendritic Cell (αDC1) Vaccine in Combination With Tumor-Selective Chemokine Modulation (Interferon-α2b, Rintatolimod, and Celecoxib) in Subjects With Chemo-Refractory Metastatic Colorectal Cancer

Is currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment.

Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Has active autoimmune disease or history of transplantation.

Is a woman of child bearing potential (WOCBP) who are pregnant or nursing.

Has a history of cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent. Subjects with a New York Heart Association classification of III or IV.

Has a history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Subjects with ulceration, bleeding or perforation in the lower bowel are not excluded.

Has prior allergic reaction or hypersensitivity to celecoxib, or NSAIDs.

Has an active infection requiring systemic therapy.

Has significant ascites or pleural effusion requiring drainage for symptom relief.

Has a known history of Human Immunodeficiency Virus (HIV).

Has known active Hepatitis B or Hepatitis C infection.

Has history of asthma, or other allergic-type reactions after taking aspirin or other NSAIDs.

Has known serious hypersensitivity reactions to peg-interferon alfa-2b or interferon alfa-2b.

Has autoimmune hepatitis.

Has hepatic decompensation (Child-Pugh score \> 6; = class B and C).

What this study is about