A Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients

Inclusion Criteria:

• Patients must have pathological or cytologically confirmed malignant melanoma with unresectable Stage III or Stage IV (including skin and distant lymph node metastasis M1a, lung metastasis M1b).
• Patients who are resistant /refractory to approved therapies, or for whom no curative therapies are available.
• Male or female, aged ≥18 and ≤70 years; ECOG performance status score of 0-2; Life expectancy of at least six months.
• For women of childbearing potential, a negative pregnancy test within 7 days prior to the first treatment.
• At least four weeks since prior other anti-tumor therapy, including endocrine, chemotherapy/radiotherapy and targeted therapy, at least six weeks since prior nitrosourea and mitomycin dosing, and have recovered from the adverse reactions due to prior therapy.
• At least 4 weeks before prior surgery.
• Must have one measurable or evaluable lesion according to RECIST 1.1
• With enough tumor tissues and diagnosed by the designated laboratory.
• Body weight >50kg.
• Without functional disorder of major organs ( laboratory examination): Neutrophils≥1.5×10^9/L, lymphocyte≥1.0×10^9/L, PLT≥100×10^9/L, Hb≥110g/L; BUN and Cr within normal range; TBIL≤1.5 times upper limit; ALT/AST≤2.5 times upper limit; PT/APTT within normal range.
• Without obvious hereditary disease.
• Must sign a written informed consent form prior to entering the study, with good compliance.

Exclusion Criteria:

• With extrapulmonary metastatic of melanoma, for instance, distant metastasis of liver, brain, bone, adrenal gland.
• With serious internal disease, including serious heart disease, cerebral vascular disease, uncontrolled diabetes, uncontrolled hypertension, serious infections, active peptic ulcer, renal failure and respiratory failure.
• Uncontrolled infectious diseases or other serious diseases, for example, HIV, Hepatitis B and Hepatitis C.
• Uncontrolled brain metastases.
• Lymphoma or leukemia patients.
• Patients who have received bone marrow, stem cells or organ transplantation.
• With immunodeficiency or autoimmune disease, leucoderma excluded.
• Allergic constitution.
• Chronic diseases needed immunosuppressive therapy or hormone therapy.
• Patients treated with steroid hormone.
• Unable to evaluate the immune status, or patients cannot comply with follow-up clinical evaluation.
• Patients diagnosed with MDS (myelodysplastic syndromes).
• Patients who are pregnant or breast-feeding.
• Women (or patients' wife) of child-bearing without effective contraceptive measures.
• Patients receiving any investigational drug or investigational treatment within 4 weeks prior to first dosing.
• With uncontrolled mental disorders.