EpCAM CAR-T for Treatment of Advanced Solid Tumors

Inclusion Criteria

• •Recurrent or refractory nasopharyngeal carcinoma and breast cancer and other solid tumors.
• •Karnofsky score of greater than or equal to 60.
• •Informed consent explained to, understood by and signed by subject/guardian. -
• •Subject/guardian given copy of informed consent
• •Recurrent or refractory EpCAM-positive nasopharyngeal carcinoma, breast cancer, gastric cancer and other epithelial tumors determined by Immunohistochemistry (IHC) or RT-PCR. EpCAM expression in tumors on IHC should be greater than or equal to grade 2 and greater than or equal to 2+ intensity score. Wherein grades are defines as: Grade 0: no staining; Grade 1: 1-25%; Grade 2: 26-50% and Grade 3: 51-100% of cell staining for EpCAM and intensity scores are: negative; 1+; 2+ and 3+ using breast cancer standard arrays as a guide for intensity.
• •Age ≥ 18 years
• •Life expectancy ≥ 6 weeks
• •Karnofsky score ≥ 60
• •Bilirubin less than or equal to 3x normal, AST less than or equal to 5x normal,
• •ALT less than or equal to 5x, serum creatinine less than or equal to 2x upper limit of normal for age, and Hgb greater than or equal to 8.0
• •Pulse oximetry of greater than or equal to 90% on room air.
• •Sexually active subjects must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion. The male partner should use a condom.
• •Available autologous transduced T lymphocytes with greater than or equal to 20% expression of EpCAM CAR determined by flow-cytometry and killing of EpCAM-positive targets greater than or equal to 20% in cytotoxicity assay.
• •Subjects should have been off other investigational antineoplastic therapy for two weeks prior to entry in this study.
• •Cyclophosphamide will be allowed 72 hours preinfusion.
• •Dexamethasone up to a total dose of 2 mg per day will be allowed if medically indicated.
• •Informed consent explained to, understood by and signed by research subjects/guardian.
• •Subject/guardian given copy of informed consent.