Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors

Exclusion Criteria

• •Uncontrolled intercurrent illnesses or medical conditions that may interfere with trial participation such as ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement or compromise the ability of the subject to give written informed consent.
• •Patients who are receiving any other investigational agents.
• •Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, Hashimoto's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• •Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• •No evidence of active uncontrolled infection (patients on antibiotics are eligible).
• •History of primary immunodeficiency.
• •History of organ transplant that requires use of immunosuppressives.
• •Known allergy or reaction to a known component of TBI-1301.
• •Untreated central nervous system metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids. If treated lesions are shown to be stable for 1 month the subject may be eligible.
• •Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
• •Current or prior use of immunosuppressive medication within 14 days before phlebotomy, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent. Oral steroid use as premedication to prevent allergic reactions to radiologic contrast is allowed.
• •Any condition that, in the opinion of the investigator, would interfere with the evaluation of TBI-1301 or interpretation of subject safety or study results.
• •Known history of tuberculosis.
• •HIV positive.
• •Active HTLV or syphilis infection.
• •Active hepatitis B infection (hepatitis B surface antigen or HBV DNA positive).
• •Active hepatitis C infection (if hepatitis C antibody positive, HCV RNA positive).
• •Has no known active central nervous system metastases and/or carcinomatous meningitis.
• •Ongoing prior toxicities related to previous anti-cancer treatments (surgery, radiotherapy or adjuvant chemo-radiation) must be recovered to \< grade 1 or baseline
• •Pregnant women are excluded.