A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer

Exclusion Criteria

• •Radiation therapy, chemotherapy, or non-cytotoxic investigational agent within 2 weeks of leukapheresis
• •Received cyclophosphamide within the past 4 months
• •Evidence of New York Heart Association class III or greater cardiac disease
• •History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within the past 12 months
• •History of congenital QT prolongation
• •Absolute QT interval of \> 470 msec in the presence of \> 4.0 mEq/L potassium and \> 1.8 mg/dL magnesium
• •Brain or leptomeningeal metastases
• •Females who are pregnant or breastfeeding
• •Hypersensitivity or intolerance to cyclophosphamide, fludarabine, or their components
• •Alcoholic liver disease or other hepatic disease with the exception of liver metastases
• •History of gastrointestinal bleeding, ulceration, or perforation
• •Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study, such as severely impaired lung function, any active (acute or chronic) or uncontrolled infection/disorders, and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study treatment
• •Current use of medications that interact with or compromise the immune system such as steroid doses \> 10 mg/day prednisone or equivalent daily within 2 weeks before leukapheresis
• •History of immunodeficiency disease or autoimmune disease, with exceptions such as Hashimoto's thyroiditis / hypothyroidism, or controlled Type 1 diabetes
• •Have any active and uncontrolled infection.
• •Active hepatitis B or hepatitis C infection or seropositive for hepatitis B, and hepatitis C antibody unless antigen negative. If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by RT-PCR and be HCV RNA negative
• •Human immunodeficiency virus (HIV) infection or seropositive for HIV antigens
• •Concurrent use of any complementary or alternative medicines
• •Unwilling or unable to comply with the study protocol
• •Prior major surgery that requires general anesthesia must be completed at least 4 weeks before leukapheresis and surgery that requires local anesthesia (except for study tissue sample collection) must be completed at least 2 weeks before leukapheresis and surgery that requires local anesthesia (except for study tissue sample collection) must be completed at least 2 weeks before leukapheresis