Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma

Exclusion Criteria

• •1. Central nerve system invasion with symptoms
• •2. Other concurrent uncontrolled malignancies
• •3. Hepatitis B infection or active period of hepatitis C, HIV infection
• •4. Other uncontrolled diseases hampering the intervention in the study
• •5. Coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious cardiovascular or cerebrovascular diseases.
• •6. Grade 2-3 or uncontrolled hypertension
• •7. History of uncontrolled mental disease
• •8. Not suitable for participation judged by researchers
• •9. Immunosuppressive agents administered due to organ transplantation, not including recent or current inhaled corticosteroid
• •10. Medical history of mental diseases or abnormities of lab tests might increase the risks of participation in study or drug administration, or interfering the results
• •11. Screening suggesting transfection efficiency of targeting cells lower than 30% or cell expansion deficiency under CD3/CD28 (cluster of differentiation 3,CD3)stimulation (less than 5 folds)
• •12. Unstable pulmonary embolism, deep venous thromboembolism or other major arterial/venous thromboembolism events develop in 30 days before the randomization. If anti-coagulation therapy is received, the treatment dose should reach stability before the randomization.
• •13. Pregnancy or lactation, or pregnancy planned during the study or in 2 months after the study
• •14. Reliable contraception not accepted during the study or in 2 months after the study. Female subjects are required to provide negative results from serum or urine pregnancy test 48 hours before therapy
• •15. Systematic active or uncontrolled infection (excluding infection of urinary tract or upper respiratory tract infection) in 14 days before the randomization
• •16. Informed consent not signed or study rules violated