GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL

Inclusion Criteria

• •1. The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;
• •2. Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;
• •3. Non Hodgkin lymphoma confirmed by cytology and genetics;
• •4. Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;
• •5. When screening, it meets the definition of recurrence or refractory: having received at least second-line or above systemic anti-tumor therapy (including autologous hematopoietic stem cell transplantation) containing rituximab (or other CD20 targeted drugs) and anthracycline drugs in the past, and disease progression (PD) or recurrence after the last treatment; Or recurrent patients who do not fully meet the above conditions but refuse chemotherapy and strongly demand CAR-T treatment;
• •6. There is no obvious evidence of central nervous system lymphoma on brain MRI;
• •7. Blood routine: Neutrophils ≥ 1.0 × 10 \^ 9/L; Hemoglobin ≥ 70 g/L; Platelets ≥ 50 × 10 \^ 9/L;
• •8. Coagulation function: fibrinogen ≥ 1.0 g/L; Activated partial thromboplastin time (APTT) ≤ ULN+10 s, prothrombin time (PT) ≤ ULN+3 s;
• •9. Liver and kidney function indicators: total bilirubin ≤ 1.5 times the upper limit of normal range (excluding Gilbert syndrome or hemolysis), ALT and AST ≤ 3.0 times the upper limit of normal range (ULN), serum creatinine ≤ 2.0 times the upper limit of normal range. If the above abnormalities are considered to be caused by tumor infiltration, they can be excluded;
• •10. Assessment of left ventricular ejection fraction (LVEF) ≥ 45% using echocardiography (ECHO) or radionuclide active vascular scanning (MUGA). (After corrective treatment and meeting the criteria, it can be included in the group);
• •11. Pulmonary function: Dyspnea ≤ CTCAE level 1 and SaO2 ≥ 92% in indoor air environment; 12. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points;
• •12. Expected survival is greater than 6 months; 14. The subjects have sufficient levels of functional organs during screening;
• •13. Female participants of childbearing age must undergo a serum pregnancy test during screening and before receiving pre-treatment chemotherapy, and the result must be negative. They are willing to use highly effective and reliable methods of contraception within one year after using the study treatment;
• •14. Male participants who engage in active sexual activity with women with reproductive potential must be willing to use highly effective and reliable methods of contraception within one year after using the study treatment. Moreover, all males are strictly prohibited from donating sperm within one year after receiving research treatment infusion during the study period.