He C X, Xue L, Qiang P, Xu H, Zhang X H, Liu X, Zhu W W, Cai X Y, Liu H L, Sun Z M, Wang X B
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.
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.
Zhonghua Xue Ye Xue Za Zhi. 2020 Jun 14;41(6):490-494. doi: 10.3760/cma.j.issn.0253-2727.2020.06.010.
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) . 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. 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 had Ⅲ-Ⅳ hematological 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 () 287-743] days and 207 (95% 123-301) days, respectively. 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.
本研究旨在探讨CD19嵌合抗原受体T细胞（CD19 CAR-T）疗法治疗复发/难治性费城染色体阳性急性B淋巴细胞白血病（R/R Ph(+) B-ALL）的安全性和疗效。回顾性分析了2016年11月至2019年4月接受CD19 CAR-T细胞疗法治疗的14例R/R Ph(+) B-ALL患者的临床资料。本研究的14例患者中，男性7例，女性7例，中位年龄为33（7-66）岁。在CAR-T细胞输注后第28天评估疗效；总缓解率为100.0%（14/14），完全缓解（CR）率为92.9%（13/14），部分缓解（PR）率为7.1%（1/14）。CAR-T细胞输注后，12例（85.7%）发生细胞因子释放综合征（CRS）：1例1级CRS，4例2级CRS，6例3级CRS，1例4级CRS。此外，1例发生CAR T细胞相关脑病综合征（CRES）；14例有Ⅲ-Ⅳ级血液学毒性；13例CR病例有B细胞发育异常。这些不良反应均可控。中位随访时间为441（182-923）天。中位总生存期（OS）和无进展生存期（PFS）分别为515 [95%置信区间（）287-743]天和207（95% 123-301）天。CD19 CAR-T细胞疗法治疗R/R Ph(+) B-ALL安全有效。然而，长期疗效有待进一步提高。
