The purpose of this study is to assess the safety, efficacy, and immunological response to
the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma.
Normal cells in the body have an established lifespan. Cancer cells on the other hand have
the ability to continue to divide into new cells indefinitely. More than 85% of cancer has
this ability because of an enzyme found in the cancer cell. The Investigational Product,
Transgenic Lymphocyte Immunization (TLI), is aimed at helping the immune system target this
enzyme found in most cancerous cells.
Subjects who meet all inclusion and exclusion criteria will undergo a leukapheresis in which
white blood cells will be collected and used to manufacture their own personal study product.
Subjects will receive 3 infusions of TLI roughly 1 month apart and will be followed over a 2
year period with routine laboratory draws, computed tomography (CT) scans and physical exams.