国产CAR-NK细胞疗法登上《柳叶刀》：安全有效治疗系统性红斑狼疮

Core Viewpoint - The treatment landscape for systemic lupus erythematosus (SLE) has significantly changed in recent years, particularly with the emergence of targeted cell immunotherapy focusing on pathogenic B cells, such as CAR-T and CAR-NK cell therapies [3][4][6]. Group 1: CAR-T Cell Therapy - CAR-T cell therapy has shown promising results in achieving disease remission in refractory severe SLE patients, but it faces challenges such as complex production, high costs, and potential risks like cytokine storms and infections [3][4]. - The study published in The Lancet highlights the efficacy and safety of allogeneic CD19 CAR-NK cell therapy in SLE, indicating it as a viable alternative to autologous CAR-T cell therapy [5][6]. Group 2: CAR-NK Cell Therapy - Allogeneic CD19 CAR-NK cell therapy has demonstrated good safety, tolerability, and therapeutic effects in a clinical study involving patients aged 18-65 with refractory or difficult-to-treat SLE [8][9]. - The study included 18 patients, with a median follow-up of over 12 months, showing that 67% of patients achieved complete DORIS remission and improved quality of life [9][11]. - The therapy was well-tolerated, with only 6% of patients experiencing mild cytokine release syndrome, and no severe adverse events related to CAR-NK therapy were reported [9][12]. Group 3: Research and Development - The research team utilized NK cells from healthy donors, genetically engineered to create off-the-shelf CD19-targeted CAR-NK cells, developed by Enraykano [8][12]. - This study represents the first human clinical trial of allogeneic CAR-NK cell therapy for SLE, potentially addressing the limitations of current autologous CAR-T therapies regarding scalability, accessibility, safety, and cost [6][12]. - The findings contribute to establishing a new paradigm for "off-the-shelf, low-toxicity, broad-target" precision treatment for autoimmune diseases [18].