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;
Single group
U16
DrugA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered before U16 treatment.
Types, frequency and severity of adverse events
Safty of U16 as measured by types, frequency and severity of adverse events after U16 Injection infusion.
Overall Remission Rate (ORR)
Efficacy of U16 as measured by ORR during the 3 months after U16 Injection infusion, which includes CR and PR.
Complete Remission (CR)
Efficacy of U16 as measured by CR during the 3 months after U16 Injection infusion.
Progression-free survival (PFS)
PFS means duration from the U16 Injection infusion to progression of lymphoma, or death for any reason.
Duration of Remission (DOR)
DOR means the duration from reaching the response (e.g., CR or PR) criteria of the therapy to the first, clearly defined progressive disease, or death for disease under investigation.
Overall Survival（OS）
OS means duration from the U16 Injection infusion to death for any reason, or the last follow-up for survival.
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