T Cell Receptor-transduced T Cells Targeting NY-ESO-1 for Treatment of Patients With NY-ESO-1- Expressing Malignancies

Inclusion Criteria

• •1. Must be pathology or cytology confirmed cancer patients with age of one year old and over；
• •2. Must be HLA-A2 positive, and cancer tissues express NY-ESO-1；
• •3. There is at least one measurable disease: diameter ≥20mm or spiral CT≥10mm；
• •4. Willing to sign a durable power of attorney；
• •5. Able to understand and sign the Informed Consent Document；
• •6. Performance status：ECOG 0-2；
• •7. Life expectancy：More than 3 months；
• •8. Patients must be willing to practice birth control for four months after receiving a lymphodepleting preconditioning regimen；
• •9. Patients with no pregnancy and lactation；
• •10. Hematopoietic： (1) Absolute neutrophil count \> 1000/mm3 without support of filgrastim； (2) Platelet count \> 100,000/mm3； (3) Hemoglobin \> 8.0 g/dL； (4) lymphocyte count \>500/mm3； (5) WBC \> 3,000/mm3；
• •11. Chemistry： (1) AST and ALT \< 2.5 times upper limit of normal； (2) Serum creatinine≤1.6 mg/dl； (3) Bilirubin ≤1.5 mg/dL（3.0 mg/dL in patients with Gilbert's syndrome）；
• •12. Seronegative for hepatitis B and C viruses；
• •13. Seronegative for human immunodeficiency virus (HIV) antibody；
• •14. More than four weeks must have elapsed since any prior systemic therapy at the time of randomization, and patients' toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo). Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria；
• •15. Six weeks must have elapsed since any prior anti-CTLA4 antibody therapy to allow antibody levels to decline. Patients who have previously received any anti-CTLA4 antibody and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsies.