The Clinical Study of CD20 CAR-T Cells in Patients With Relapsed and Refractory B Cell Non-Hodgkin Lymphoma

Inclusion Criteria:

* 1\. Patients with CD20+ relapsed or refractory B cell Non-Hodgkin lymphoma, which includes but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, transformed follicular lymphoma, marginal-zone lymphoma, mantle-cell lymphoma, small B-cell lymphoma, are eligible for inclusion in this study must meet one of the following criteria:

  1. Relapsed or refractory as defined by not achieving a PR after a second-line drug therapy such as CD20 monoclonal antibodies, or achieving a PR but the disease has progressed, or chieving a CR but the disease has relapsed.
  2. Relapse after autologous stem cell transplantation (SCT) within 1 year.
* 2\. Adult subjects between 18 and 70 years of age, inclusive.
* 3\. Life expectancy \> 3 months.
* 4\. ECOG score between 0 and 1.
* 5\. Liver, Renal, Heart and Lungs function defined as:

  1. Creatininec≤1.5 ULN;
  2. ALT/AST ≤2.5 ULN;
  3. Total Bilirubin≤1.5×ULN;
  4. Pulse oxygenation≥92%;
  5. Left Ventricular Shortening Fraction (LVSF)≥50%;
  6. Echocardiogram (ECHO) shows no obvious pericardial effusion.
* 6\. According to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma, the lesions must meet the minimum size requirement of being \>15 mm in longest diameter (LDi).
* 7\. Subjects could comprehend the clinical study and able to provide written consent at the time of consent or assent.

Exclusion Criteria:

* 1\. Pregnant or lactating women, or women with pregnancy plans within 6 months.
* 2\. HBsAg or the titer of HBV was not in the range of normal reference value; positive for presence of HCV antibody or HCV RNA in peripheral blood; positive for presence of human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2).
* 3\. Severe heart disease: include but not limited to Unstable angina pectoris, myocardial infarction (within 6 months before screening), Congestive heart failure (New York Heart Association \[NYHA\] Classification ≥ III).
* 4\. Previously received other CART therapy or transgenic cell therapy.
* 5\. The subjects participated in clinical trials within 6 months before screening.
* 6\. Subjects who were receiving systemic steroid therapy and determined by the researchers to require long-term use of systemic steroid therapy except for inhalation or local use before screening.
* 7\. Subjects who had more than 2 years of autoimmune disease history (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that caused organ damage or subjects who needed to take systemic immunosuppressants;
* 8\. Any unstable systemic disease, including but not limited to, liver, kidney or metabolic diseases requiring drug treatment.
* 9\. Autologous transplantation or allotransplantation was performed within 6 months after admission.
* 10\. Evidence or history of central nervous system involvement in lymphoma.
* 11\. Subjects with active bleeding caused by the involvement of the original lesion in the digestive tract.
* 12\. Subjects with active infectious diseases who received systematic antibiotic treatment within 2 weeks of admission.
* 13\. Other subjects judged by the researchers to be unsuitable for admission to the study.