Study of Safety and Efficacy of C-CAR011 in B-NHL Patients

Exclusion Criteria

• •2. Disease relapsed or progressed after most recent therapy
• •3. Relapsed within 12 months after prior autologous SCT
• •4. All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1)
• •5. At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5 cm)
• •6. Expected survival ≥ 12 weeks
• •7. ECOG score 0-1
• •8. Adequate pulmonary, hepatic, renal and cardiac function
• •9. At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy therapy) prior to leukapheresis,or at least 4 weeks from monoclonal antibody therapy prior to CAR T infusion
• •10. No contraindications of leukapheresis
• •11. Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial
• •1. Prior treatment with CAR T therapy or any other genetically modified T cell therapy
• •2. Relapse after allogeneic hematopoietic stem cell transplantation
• •3. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
• •4. Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected people
• •5. Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications
• •6. QT interval prolongation≥450 ms
• •7. A history of epilepsy or other central nervous system disorders
• •8. No evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
• •9. The patient had a history of other primary cancers, with the following exceptions
• •* 1 Excisional non-melanoma such as cutaneous basal cell carcinoma
• •* 2 Cured in situ carcinoma such as cervical cancer, bladder cancer or breast cancer
• •10. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
• •11. Used of systemic steroids within two weeks (using inhaled steroids is an exception)
• •12. Women who are pregnant or lactating or have breeding intent in 6 months
• •13. Participated in any other clinical trial within three months
• •14. The investigators believe that any increase in the risk of the subject or interference with the results of the trial