[Expert consensus on the management practice of CD19 CAR-T cell therapy for B-cell lymphoma in China (2025 edition)].

Abstract

In recent years, the incidence of B-cell non-Hodgkin lymphoma (B-NHL) in China has shown a steady increase, accounting for approximately 85%-90% of all lymphomas. Although standard immunochemotherapy regimens such as R-CHOP have led to long-term remission in some patients, approximately 30%-40% still experience relapse or refractory disease, with dismal prognosis and a median survival of less than one year. For patients who fail multiple lines of therapy, conventional options such as chemotherapy, radiotherapy, or hematopoietic stem cell transplantation offer limited benefits, highlighting an urgent need for innovative treatments. Chimeric antigen receptor T-cell (CAR-T) therapy, a breakthrough form of adoptive cellular immunotherapy, modifies autologous T cells to specifically recognize and eliminate malignant B cells, thereby achieving significant survival improvement in patients with relapse or refractory B-NHL. The clinical research and clinical application of CAR-T in the treatment of hematological tumors in China are in a state of rapid development. At present, there are two targeting CD19 CAR-T cells for the treatment of B-cell lymphoma, which gradually changed the diagnosis and treatment practice of lymphoma in China. At the same time, the clinic is actively exploring and improving the whole-process management experience of CAR-T therapy in lymphoma patients. So the Lymphoma Quality Control Expert Committee of the National Cancer Quality Control Center organized experts to form the consensus through discussion and revision many times, aiming to provide better guidance for clinicians to standardize the whole-process management of CAR-T cell therapy for B-cell Lymphoma, and further improve the survival benefits of patients.

近年来，中国B细胞非霍奇金淋巴瘤（B-NHL）的发病率呈持续上升趋势，占全部淋巴瘤的约85%～90%。尽管标准免疫化疗［如R-CHOP方案（利妥昔单抗、环磷酰胺、多柔比星、长春新碱、泼尼松）］使部分患者获得长期缓解，但仍有约30%～40%的患者出现复发或难治情况，预后极差，中位生存时间不足1年。对于多线治疗失败的患者，传统化疗、放疗或造血干细胞移植的疗效有限，迫切需要新的治疗策略。嵌合抗原受体T细胞（CAR-T）作为一种突破性免疫细胞疗法，通过对自体T细胞进行基因修饰，使其特异识别并清除恶性B细胞，显著改善了复发或难治B-NHL患者的预后。中国CAR-T治疗血液肿瘤的临床研究和临床应用正处于高速发展状态，目前在中国已有2款靶向CD19 CAR-T获批用于B-NHL治疗，逐步改变了中国淋巴瘤的诊疗实践。与此同时，临床也在积极探索和改善CAR-T治疗在淋巴瘤患者中的全程管理经验。鉴于此，国家肿瘤质控中心淋巴瘤质控专家委员会组织相关领域专家，经过多次讨论、反复修订，最终形成《CD19 CAR-T治疗成人B细胞非霍奇金淋巴瘤管理实践专家共识（2025版）》，旨在梳理CAR-T治疗相关证据，结合临床实践，为临床医师应用CAR-T治疗B-NHL全程管理规范化提供更好的指导，进一步提高淋巴瘤患者生存获益。.