TABLE OF CONTENTS 1.0 BACKGROUND AND RATIONALE ......................................................................................... 5 1.1 Overview ................................................................................................................................ 5 1.2 Colorectal Cancer (CRC) Statistics ........................................................................................ 5 1.3 Colorectal Cancer (CRC) Genetics ........................................................................................ 5 1.4 Cancer Neoantigens ............................................................................................................... 7 1.5 Adjuvant Treatment for CRC: Current Standard ................................................................... 7 1.6 Dend ritic Cells ....................................................................................................................... 8 1.7 Regulatory T cells .................................................................................................................. 8 1.8 Organoid Cultures .................................................................................................................. 8 1.9 Study Rationale ...................................................................................................................... 9 1.10 Study Design .......................................................................................................................... 9 2.0 OBJECTIVES ................................................................................................................................ 9 2.1 Primary Objective .................................................................................................................. 9 2.2 Secondary Objective .............................................................................................................. 9 2.3 Exploratory Objectives ........................................................................................................... 9 3.0 ELIGIBILITY CRITERIA ......................................................................................................... 10 3.1 Inclusion Criteria .................................................................................................................. 10 3.2 Exclusion Criteria ................................................................................................................ 10 4.0 REGISTRATION ........................................................................................................................ 11 5.0 SUBJECT RECRUITMENT AND SCREENING .................................................................... 11 6.0 CONCOMITANT THERAPY .................................................................................................... 12 7.0 INVESTIGATIONAL PRODUCTS .......................................................................................... 12 7.1 Dendritic Cell Vaccines (mDC3/8 vaccine with and without influenza) ............................. 12 7.1.1 Agent Description .....................................................................................................