A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma

Inclusion Criteria: * Male or female subjects ≥18 years of age and able to understand and give written informed consent * Women subjects of childbearing potential (WOCBP) and male subjects must be using an effective method of contraception * Histologic diagnosis of malignant melanoma: * Melanoma primary completely resected with negative margins. Primary surgery must be \<8 weeks from leukapheresis procedure * Stage IIIB or Stage IIIC according to the American Joint Committee on Cancer (AJCC) Tumor-Node-Metastasis (TNM) criteria (Appendix 2) OR previously resected Stage I or II melanoma that recurs as Stage IIIB or IIIC. * HLA-A2 positive * ECOG Performance Status of 0, 1 or 2 (Appendix 3) * Adequate bone marrow, hepatic, and renal function: * WBC ≥1500/μL * ANC ≥1000/μL * Platelets ≥100 × 103/μL * Hemoglobin ≥9 g/dL * Creatinine ≤2 ULN * AST ≤2 ULN * Bilirubin ≤2 ULN (except for subjects with Gilbert's Syndrome who must have a total bilirubin \<3.0 mg/mL) * Negative screening tests for HIV, Hepatitis B and C Exclusion Criteria: * Female subjects, their partners and male subjects who are unwilling or unable to practice abstinence or use a barrier method (condoms) during intercourse to minimize the risk of exposure to the blood-borne transgene for the entire period of the study and for up to 8 weeks after the last TLI infusion * Known allergy to DMSO * Any malignancy from which the subject has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix * Primary ocular or mucosal melanoma * Autoimmune disease: subjects with a documented history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]) that has or may require systemic therapy * Concomitant therapy with any anticancer agent; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non cancer-related illnesses). Replacement doses of corticosteroids are allowed in subjects with adrenal insufficiency * Prior biologic therapy for melanoma