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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
SupermAb (BeiJing) Biotech Co., Ltd
Collaborator