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

This is an interventional treatment trial for Relapsed and Refractory B Cell Lymphoma focused on measuring CD20 CAR T Cells, Safety, tolerance and efficacy Read More

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.