Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cosmo Bioscience
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
