柏林夏里特医院的研究人员在全球首次临床试验中使用CD19 CAR T细胞疗法治疗难治性类风湿关节炎，取得显著成效1。该试验纳入6名患者（3名女性、3名男性，年龄31-69岁），这些患者均曾接受8种靶向或生物疗法但效果不佳1。所有参与患者的疾病活动性均明显下降，其中3名患者在长达12个月的随访期间实现无药物缓解1。
治疗过程采用短期化疗准备后进行单次细胞输注的方案1。治疗后观察到的不良反应仅为暂时性、轻度至中度的细胞因子释放综合征，未见严重神经并发症或其他严重不良事件1。研究发现自身免疫抗体显著下降，而疫苗产生的保护性抗体（水痘、破伤风）仍可检测到1。该治疗通过清除致病B细胞并重置免疫系统的病理记忆来发挥作用1。
第二阶段试验将纳入10名额外患者，并与已批准的靶向B细胞的类风湿关节炎药物进行对比1。相关研究已发表在《自然医学》期刊1。
Researchers at Charité Hospital in Berlin have successfully used CD19 CAR T-cell therapy, a treatment originally developed for cancer, to treat six patients with severe rheumatoid arthritis in the first clinical trial of its kind globally 1. All six patients experienced significant reduction in disease activity, with three achieving drug-free remission that persisted for up to twelve months of follow-up 1.
The trial enrolled patients aged 31 to 69 years—three women and three men—who had all previously undergone treatment with eight different targeted or biologic therapies without adequate response 1. Each patient received short-term chemotherapy preparation before undergoing a single infusion of CD19 CAR T cells 1. The therapy works by eliminating the B cells responsible for autoimmune disease and resetting pathological immune memory 1.
Safety monitoring revealed only temporary, mild-to-moderate cytokine release syndrome as an adverse effect, with no severe neurological complications or other serious adverse events reported 1. Notably, while autoimmune antibodies declined significantly following treatment, protective antibodies generated by vaccines against varicella and tetanus remained detectable 1. A second-phase trial will expand to ten additional patients and compare outcomes with approved B-cell-targeting rheumatoid arthritis medications 1. The findings were published in Nature Medicine 1.
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