DC Vaccine in Pancreatic Cancer

This is a single arm open label trial that will assess the safety and tolerability of mature
dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic
adenocarcinoma.

Eligible patients that provide written informed consent will undergo apheresis to collect
blood mononuclear cells for vaccine production approximately 1 week prior to vaccine
infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously 3 to 4
days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all
subjects will receive autologous dendritic cells pulsed with mutant KRAS peptides
corresponding to the subject's specific tumor mutation and human leukocyte antigen type. On
Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster
vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second
apheresis procedure will be performed at the end of study to monitor the immune response to
the vaccine. Information will be gathered from usual clinic visits for approximately 1 year
following the End of Treatment Study Visit to evaluate for disease progression.

Inclusion Criteria:

- Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated)
pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence
of disease.

- Expression of one or more of the following HLA class I alleles: HLA-A02, HLA-A03,
HLA-A11, HLA-B07 and HLA-C08.

- Male or female, age 18+

- ECOG performance status 0-1

- Certain required laboratory values, performed within 14 days prior to consent

- Subjects of reproductive potential must agree to use a medically accepted birth
control method during the trial and for at least two months following the trial.

- Provide written informed consent

Exclusion Criteria:

- Prior treatment with more than one line of cytotoxic chemotherapy. Radiotherapy is not
considered a line of therapy.

- Prior malignancy (except non-melanoma skin cancer) within 3 years.

- Pregnant or nursing women.

- Concurrent treatment with systemic immunosuppressants, including corticosteroids (e.g
prednisone), calcineurin inhibitors (e.g tacrolimus, cyclosporine), antiproliferative
agents (e.g mycophenolate mofetil, azathioprine) within 2 weeks of eligibility
confirmation. Local (inhaled or topical) steroids or replacement dose prednisone (≤ 10
mg daily) are permitted.

- Known chronic viral infections including hepatitis B, hepatitis C, and HIV.

- Known allergy to eggs.

- Prior history of uveitis or autoimmune inflammatory eye disease.

- Uncontrolled intercurrent illness.

- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or study
results.