A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
• Age≥18 years old,gender is not limited;
• Expected survival \> 12 weeks;
• ECOG score 0-2;
• B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to the 2016 World Health Organization (WHO) classification and diagnostic criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed filter Alveolar lymphoma (TFL) and high-grade B-cell lymphoma (HGBCL);
• Pathology demonstrated that B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:
‣ Relapsed and refractory B-cell non-Hodgkin's lymphoma, after standard first-line treatment and at least 2 courses of second-line treatment without remission and relapse (the previous use of CD20-targeted drugs and anthracyclines were needed);
⁃ Relapse of B-cell non-Hodgkin lymphoma after stem cell transplantation, regardless of previous treatments.
• The venous access required for collection can be established and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥80g/L, neutrophils ≥1.0×10\^9/L, platelets ≥75×10\^9 / L;
• According to the Lugano 2014 criteria, there should be at least one measurable tumor lesion;
• Liver, kidney and cardiopulmonary functions meet the following requirements:
‣ Serum creatinine≤1.5×ULN or creatinine clearance rate≥50mL/min (GockcroftGault formula);
⁃ Cardiac ejection fraction \>50%, no clinically significant pericardial effusion detected, no clinically significant pleural effusion detected;
⁃ Baseline blood oxygen saturation\>92%;
⁃ Total bilirubin≤1.5×ULN(Gilbert syndrome≤5×ULN);
⁃ ALT and AST≤3×ULN (AST and ALT ≤5×ULN in patients with liver metastases);
• Able to understand and sign the Informed Consent Document.