DC Vaccine in Colorectal Cancer

This is a pilot study to assess the safety and tolerability, as well as the immune response
rate, of mDC3 vaccine in patients with colorectal cancer.

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 mutated peptides. 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 stage I and II hypermutated colorectal cancer (CRC)

- Surgically resected disease

- Male or female patients 18+ years of age

- ECOG performance status 0-1

- Certain 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 malignancy within 3 years that may put subject at risk

- Pregnant or nursing women

- Concurrent treatment with systemic immunosuppressants including corticosteroids,
calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local
(inhaled or topical) steroids or replacement dose prednisone are permitted.

- Known allergy to eggs

- Any uncontrolled intercurrent illness or active ongoing infection thta may put subject
at additional risk