The study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.
Patients who are willing to sign the informed consent form and have good compliance;
Aged 18-70 years, male or female;
CD20-positive B-cell non-Hodgkin's lymphoma with immunohistochemistry(IHC), with the following diagnostic: Diffuse large B cell lymphoma (DLBCL), or Primary mediastinal large B cell lymphoma (PMBCL), or Follicular lymphoma transformed large B cell lymphoma (TFL) , or High grade B cell lymphoma(HGBCL);
Previously received≥2nd-line adequate therapy or autologous hematopoietic stem cell transplantation (ASCT), including: a) Received anthracycline-containing drugs and rituximab or other CD20-targeted drugs (except CD20-negative tumors); b) Definition of line: Stable disease (SD) after receiving a first-line therapy for at least 4 cycles or progressive disease (PD), and SD after a second-line therapy for at least 2 cycles or PD; c) For transformed follicular lymphoma (TFL), patients must be treated adequately against FL, and after transformation, must have received at least once the therapy against TFL, and become relapsed or refractory after the last therapy;
Patients with other malignant tumors, except for disease-free survival for more than 3 years or carcinoma in-situ;
Patients with lymphoma involved with atrium or ventricle；
Used immunosuppressants, hormones or high-dose chemotherapy within 2 weeks before signing the informed consent form, or planned to use immunosuppressants or hormones(specifically referring to systemic therapy) before apheresis, except for local or inhaled corticosteroid therapy;
Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive; hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection; hepatitis C antibody (HCV-Ab) positive and HBV-RNA copies being more than the lower limit of detection; anti-treponemia pallidum antibody (TP-Ab) positive; Human immunodeficiency virus (HIV) antibody positive; EBV-DNA, and CMV-DNA copies being more than the lower limit of detection;