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.
Trial participants voluntarily sign the informed consent form and have good compliance;
Age ≥18 years and ≤70 years at the time of signing the informed consent form; male or female trial participants are eligible;
Indication: B-cell non-Hodgkin lymphoma that is CD20-positive as demonstrated by immunohistochemistry (IHC) staining of prior tumor tissue samples or by bone marrow cells, and consistent with the 2017 WHO classification of NHL, including: diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL) to large B-cell lymphoma, and high-grade B-cell lymphoma (HGBCL);
Prior treatment with ≥2 lines of adequate therapy or autologous hematopoietic stem cell transplantation (ASCT). Adequate therapy includes: a) Must have received adequate treatment including anthracyclines and rituximab or other CD20-targeted agents (except for CD20-negative tumors); b) Lines of therapy: best response to first-line treatment was progressive disease (PD), or best response to at least 4 cycles of first-line treatment was stable disease (SD), or best response to at least 6 cycles of first-line treatment was PR; PD again during/after the last line of treatment (second-line or beyond), or best response to at least 2 cycles of the last line of treatment was SD. c) For TFL to large B-cell lymphoma: prior to transformation, the participant must have received adequate treatment for FL, and has relapsed or is refractory during/after the last line of treatment after transformation; if the initial diagnosis is transformed lymphoma, the participant must have received ≥2 lines of therapy and has relapsed or is refractory during/after the last line of treatment;
Concurrent other malignancies, except for malignancies with disease-free survival exceeding 3 years and carcinoma in situ;
Trial participants with lymphoma infiltration of the cardiac atria or ventricles;
Use of immunosuppressants, high-dose chemotherapy within 2 weeks before signing the informed consent form, or use of hormones within 3 days, or planned requirement for immunosuppressants or hormones after signing the informed consent form and before/after apheresis; specifically referring to systemic therapy, excluding local or inhaled corticosteroid therapy;
History of immunodeficiency, including human immunodeficiency virus (HIV) infection; positive anti-Treponema pallidum antibody (TP-Ab); hepatitis B virus infection (hepatitis B surface antigen [HBsAg] positive and hepatitis B virus deoxyribonucleic acid [HBV-DNA] quantification > lower limit of detection); hepatitis C virus infection (hepatitis C virus [HCV] antibody positive and hepatitis C virus ribonucleic acid [HCV-RNA] quantification > 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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