A Single-Patient Study Using AGS 006

• Treatment-emergent changes in vital signs (blood pressure, heart rate, respiratory rate, and body temperature) from baseline values obtained prior to each investigative treatment [ Designated as safety issue: Yes ]
  
• Incidence of treatment-emergent adverse events graded according to the Common Terminology Criteria for Adverse Events [ Designated as safety issue: Yes ]
  
• Treatment-emergent adenopathy, tenderness, or inflammation (inguinal and axillary) assessed before and after each dose [ Designated as safety issue: Yes ]
  
• Treatment-emergent changes in autoimmunity evaluations as measured by clinical signs and symptoms and laboratory assessments at periodic intervals during the Treatment Period. [ Designated as safety issue: Yes ]
  
• Treatment-emergent changes in localized injection site reactions following each dose [ Designated as safety issue: Yes ]
  

• Assessment of progression-free survival (PFS) estimated from the date of subject registration - Standard Response Evaluation Criteria in Solid Tumors (RECIST) definitions of progressive disease (PD) will contribute to estimating the interval for PFS. [ Designated as safety issue: No ]
  
• T cell response to RNA-electroporated DCs will be assessed by flow cytometry using blood cells collected according to protocol time and events [ Designated as safety issue: No ]
  
• Positive immune response [ Designated as safety issue: No ]
  
• Feasibility [ Designated as safety issue: No ]
  

Single-patient, open-label clinical study:

• Events during Pre-Treatment Period:

  1. Resection of pancreatic cancer,
  2. RNA acquisition from tumor specimen,
  3. RNA amplification,
  4. Infectious disease testing,
  5. Autoimmune disease testing,
  6. Two blood draws for immune response monitoring,
  7. Production leukapheresis, and
  8. Dendritic cell electroporation with RNA and immunotherapeutic production;

• Events during Induction Period:

  1. Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses,
  2. Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and
  3. One leukapheresis (Week 14) for immune response monitoring;

• Events during Booster Period:

  1. Dose every 3 months until progression or 2 years after first AGS treatment,
  2. Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and
  3. One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and,

• Events during study Close-Out:

  1. Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose