EGFR-BATs in Treating Participants with Locally Advanced or Metastatic Pancreatic Cancer

Inclusion Criteria

• Histological or cytological proof of pancreatic adenocarcinoma; must have locally advanced or metastatic pancreatic cancer and received at least one dose of chemotherapy (any treatment line) and may have responding, stable or progressive disease
• Expected survival >= 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Left ventricular ejection fraction (LVEF) >= 45% at rest (multigated acquisition [MUGA] scan or echocardiogram [Echo])
• Age >= 18 years at the time of consent (Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information)
• Females of childbearing potential, and males, must be willing to use an effective method of contraception
• Females of childbearing potential must have a negative pregnancy test within 10 days prior to “on study” status; if a urine or serum test is positive or cannot be confirmed as negative, the other (urine or serum pregnancy test, whichever was not performed first) will be required
• Absolute lymphocyte count >= 400/mm^3 within 10 days prior to “on study” status
• Absolute neutrophil count (ANC) >= 1,000/mm^3 within 10 days prior to “on study” status
• Platelets >= 75,000/mm^3 within 10 days prior to “on study” status
• Hemoglobin >= 8 g/dL within 10 days prior to “on study” status
• Serum creatinine < 2.0 mg/dl OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) >= 50 ml/mm within 10 days prior to “on study” status * Creatinine clearance should be calculated per institutional standard
• Serum total bilirubin =< 2 mg/dl (biliary stent is allowed) within 10 days prior to “on study” status
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 5.0 times normal within 10 days prior to “on study” status
• Alpha 1,3 galactose IgE (“alpha gal”) < 0.35 IU/ml or “negative” within 10 days prior to “on study” status

Exclusion Criteria

• Known hypersensitivity to cetuximab or other EGFR antibody
• Treatment with any investigational agent within 14 days prior to first study intervention (apheresis) for protocol therapy
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first study intervention (apheresis); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to “on-study” status
• Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• Is human immunodeficiency virus (HIV) positive or has evidence of active hepatitis C virus or active hepatitis B virus; if initial hepatitis C antibody test shows a positive result, the patient should have a hepatitis viral load test to confirm; if initial HIV or hepatitis B virus testing shows a positive result, no further testing will be done
• Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
• Has an active infection requiring systemic therapy
• A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy
• Has a known history of active TB (Bacillus tuberculosis)
• Has had prior chemotherapy, radiation, hormonal, monoclonal antibody (mAb) or targeted small molecule therapy, within 2 weeks prior to the first study procedure (apheresis); subjects who have not recovered to < grade 3 from an adverse event due to a previously administered agent are not eligible
• Has received a live vaccine within 30 days of first study procedure (apheresis)
• History of a recent myocardial infarction (within one year), a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications
• Has history of another malignancy within the past 5 years; exceptions include: * Basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy * In situ cervical cancer
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• Females must not be breastfeeding
• History of a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 3 months of “on study” status
• Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant