CD19 CAR-T细胞治疗复发难治Ph^+急性B淋巴细胞白血病14例疗效及安全性  

Safety and efficacy of CD19-targeted CAR-T cells in 14 patients with refractory/relapsed Philadelphia chromosome-positive acute B-precursor lymphoblastic leukemia

作　　者：何彩霞 薛磊 强萍 徐慧[2] 张旭晗 刘欣[2] 朱薇波 蔡晓燕 刘会兰 孙自敏 王兴兵 He Caixia;Xue Lei;Qiang Ping;Xu Hui;Zhang Xuhan;Liu Xin;Zhu Weibo;Cai Xiaoyan;Liu Huilan;Sun Zimin;Wang Xingbing(Anhui Provincial Hospital Affiliated of Anhui Medical University,Hefei 230001,China;Department of Hematology,The First Affiliated Hospital of University of Science and Technology of China,Division of Life Sciences and Medicine,University of Science and Technology of China,Hefei 230001,China)

机构地区：[1]安徽医科大学附属省立医院,合肥230001 [2]中国科学技术大学附属第一医院(安徽省立医院)血液科,合肥230001

出　　处：《中华血液学杂志》2020年第6期490-494,共5页Chinese Journal of Hematology

基　　金：安徽省科技重大专项(18030801126);安徽省科技攻关项目(1604a0802071)。

摘　　要：目的研究靶向CD19的嵌合抗原受体T细胞(CAR-T细胞)治疗复发难治Ph染色体阳性急性B淋巴细胞白血病(R/R Ph+ B-ALL)的安全性及有效性。方法对2016年11月至2019年4月采用CD19 CAR-T细胞治疗的14例R/R Ph+ B-ALL患者的临床资料进行回顾性分析。结果 14例患者中,男7例,女7例,中位年龄33(7~66)岁。输注CAR-T细胞后第28天近期疗效:总反应率(ORR)为100.0%(14/14),其中完全缓解(CR)率为92.9%(13/14);部分缓解(PR)率为7.1%(1/14)。CAR-T细胞治疗后有12例(85.7%)发生细胞因子释放综合征(CRS),其中1级1例、2级4例、3级6例、4级1例;1例(例3)发生CAR-T细胞相关脑病综合征(CRES);全部14例患者均有Ⅲ~Ⅳ级血液学不良反应;13例CR患者均发生B细胞发育不全。上述不良反应均可控。中位随访441(182~923)d,中位总生存期、无进展生存期分别515(95%CI 287~743)d、207(95%CI 123~301)d。结论 CD19 CAR-T细胞治疗复发难治性Ph+ B-ALL安全有效,短期疗效显著,长期疗效有待进一步提高。Objective This study aimed to examine the safety and efficacy of CD19 chimeric antigen receptor T cell(CD19 CAR-T)therapy in relapsed/refractory Philadelphia chromosome-positive acute B-precursor lymphoblastic leukemia(R/R Ph+B-ALL).Methods The clinical data of 14 patients with R/R Ph+B-ALL treated with CD19 CAR-T cell therapy from November 2016 to April 2019 were retrospectively analyzed.Results Among the 14 patients in this study,7 were male and 7 were female,with a median age of 33(7-66)years old.The efficacy was evaluated on the 28th day following CAR-T cells infusion;the overall response rate was 100.0%(14/14),the complete response(CR)rate was 92.9%(13/14),and the partial response(PR)rate was 7.1%(1/14).After CAR-T cells infusion,12 cases(85.7%)developed cytokine release syndrome(CRS):1 case of grade 1 CRS,4 cases of grade 2 CRS,6 cases of grade 3 CRS,and 1 case of grade 4 CRS.Moreover,one case developed CAR T-cell-related encephalopathy syndrome(CRES);14 cases hadⅢ-Ⅳhematological toxicity;and 13 CR cases had B cell dysplasia.These adverse reactions were all controllable.The median follow-up time was 441(182-923)d.The median overall survival(OS)and progression-free survival(PFS)were 515[95%confidence interval(CI)287-743]days and 207(95%CI 123-301)days,respectively.Conclusion CD19 CAR-T cell therapy is safe and effective for R/R Ph+B-ALL treatment.However,the long-term efficacy needs to be further improved.

关 键 词：嵌合抗原受体T细胞 CD19 白血病 B淋巴细胞 急性 费城染色体 酪氨酸激酶抑制剂 

分 类 号：R733.71[医药卫生—肿瘤]