The purpose of this study is to determine whether AcNK-Sup003 cell injection is safe and effective in the treatment of elapsed or refractory B-cell non-Hodgkin's lymphoma.
Signed an informed consent form in writing and is able to comply with the visits and related procedures specified in the protocol.
Age ≥18 years old, with an expected survival of more than 3 months.
Confirmed by pathology to have CD20+ relapsed or refractory B-cell non-Hodgkin's lymphoma (according to the WHO 2016 lymphoma classification standards), including but not limited to diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and grade 3b follicular lymphoma.
Relapse, non-response, or progression after hematopoietic stem cell transplantation.
Primary central nervous system lymphoma, or active central nervous system involvement or symptoms of central involvement.
Accompanying active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, immune thrombocytopenia, etc.), uncontrolled multi-cavity effusions; presence of grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening.
Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.
Prolonged QT interval corrected by the Fridericia formula (QTcF), >450 ms for males; >470 ms for females.
Single group
AcNK-Sup003 cell injection solution
DrugThe AcNK technology has successfully achieved the direct, covalent, and directional conjugation of intact antibodies which includes the Fc domain to the surface of NK cells via a one-step enzymatic reaction. This novel approach yields a non-genetically modified NK cell that is conjugated with dual-targeting antibodies, referred to as AcNK. Specifically, AcNK-Sup003 cells are cryopreserved NK cells that have been conjugated with bispecific antibodies target both CD20 and CD19.
Dose-limiting toxicities (DLTs)
serious adverse events (SAEs)
The incidence, severity, and relationship to the study drug of all adverse events (AEs), including serious adverse events (SAEs). Adverse events would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Maximum tolerated dose
Objective response rate (ORR)
Clinical efficacy would be evaluated according to 2014 Lugano criteria.
Duration of response (DOR)
Clinical efficacy would be evaluated according to 2014 Lugano criteria.
Progression-free survival (PFS)
PFS is defined as the interval between a subject's receipt of the first dose of AcNK-Sup003 cell infusion and the first assessment of disease progression or death.
Overall survival (OS)
OS is defined as the interval between a subject's receipt of first AcNK-Sup003 cell infusion and death from any cause.
Changes in CD19 and/or CD20-positive B cells
Donor-specific HLA antibodies in the blood
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
SupermAb (BeiJing) Biotech Co., Ltd
Collaborator
