中华临床免疫和变态反应杂志2025,Vol.19Issue(6):397-405,9.DOI:10.3969∕j.issn.1673-8705.2025.06.001
BCMA-CD19双靶点CAR-T细胞治疗在狼疮性肾炎中的长期疗效及安全性评估
Long-term efficacy and safety of BCMA-CD19 compound CAR-T cell therapy in lupus nephritis
摘要
Abstract
Objective To evaluate the long-term efficacy and safety of BCMA-CD19 compound chimer-ic antigen receptor T-cell(CAR-T)therapy in patients with lupus nephritis(LN).Methods Eleven re-fractory LN patients who received BCMA-CD19 compound CAR-T infusion were retrospectively analyzed.After a median follow-up of 30(IQR 30-33)months,clinical response rates were assessed.Nine patients underwent serial renal biopsies;changes in histopathology,activity index(AI)and chronicity index(CI)were com-pared with baseline.Results Six months post-infusion,mean SLEDAI-2K score fell from(13.5±2.3)to(4.3±1.6)(Δ=-9.18;P<0.001).All11 patients(100%)achieved low lupus disease activity state(LLDAS),and7(63.6%)met the DORIS remission criteria.Response rates remained stable at12,24 and 30 months without significant fluctuation(P>0.05).Repeat biopsies revealed marked reduction in immunofluorescence intensity and a significant decrease in AI[ΔAI=(-1.67±0.52),P=0.01],whereas CI showed a non-significant upward trend(P=0.067).No tuberculosis,hepatitis virus or malignancy was observed during follow-up.Conclusions BCMA-CD19 compound CAR-T therapy induces sustained clinical remission for up to 3 years in refractory LN,substantially attenuates renal pathological activity,and displays an acceptable safety profile.Larger studies with longer surveillance are warranted to confirm durability and eluci-date underlying mechanisms.关键词
狼疮性肾炎/系统性红斑狼疮/BCMA/CD19/CAR-TKey words
lupus nephritis/systemic lupus erythematosus/BMCA/CD19/CAR-T引用本文复制引用
何善智,郭子文,叶晴,黄桂英,王伟佳,梁颖文,袁润强,丁菱,王俊贤,王敏,王明霞,邹婵娟,颜丝语,陈润杰,陆子骥..BCMA-CD19双靶点CAR-T细胞治疗在狼疮性肾炎中的长期疗效及安全性评估[J].中华临床免疫和变态反应杂志,2025,19(6):397-405,9.基金项目
中山市社会公益科技研究项目(2023B1034) Zhongshan City Social Welfare and Basic Research Project(2023B1034) (2023B1034)