Objective: This study aimed to evaluate the safety and efficacy of humanized CD19-targeted chimeric antigen receptor T-cell (CAR-T) in patients with relapsed/refractory acute B cell lymphoblastic leukemia (R/R B-ALL) . Methods: The clinical data of 41 patients with R/R B-ALL treated with humanized CD19-targeted CAR-T cells in the First Affiliated Hospital of Zhejiang University School of Medicine from February 2020 to July 2021 were analyzed. Results: Cytokine release syndrome occurred in all patients, and 63.4% (26/41) were grades 1-2. Immune effector cell-associated neurotoxicity syndrome developed in three patients. On median day 15 (9-47) , the complete remission rate was 95.1% (39/41) , of which 38 patients tested negative for bone marrow minimal residual disease detected by flow cytometry. Among the 39 patients with complete remission, 17 patients did not receive further treatment, and 70.6% (12/17) remained in remission at the end of follow-up, with a progression-free survival of 11.6 months of the two patients with the earliest infusion. Another 17 patients underwent consolidation allogeneic hematopoietic stem cell transplantation (10 cases) or CD22 CAR-T cell sequential therapy (seven cases) after remission, and 76.5% (13/17) of the patients were still in remission at the end of follow-up. The remaining five patients who did not receive consolidation therapy relapsed at a median of 72 (55-115) days after CAR-T cell therapy. Conclusion: In patients with R/R B-ALL, the humanized CD19-targeted CAR-T cells had a high response and manageable toxicity.
目的： 观察人源化靶向CD19嵌合抗原受体T细胞（CAR-T）治疗复发/难治急性B淋巴细胞白血病（R/R B-ALL）患者的有效性及安全性。 方法： 分析2020年2月至2021年7月于浙江大学医学院附属第一医院接受人源化靶向CD19 CAR-T细胞治疗的41例R/R B-ALL患者的有效性和安全性。 结果： 中位第15（9~47）天，41例患者的完全缓解率为95.1%（39/41），其中38例患者骨髓经流式细胞术检测微小残留病灶阴性。39例完全缓解的患者中17例未接受进一步治疗，70.6%（12/17）的患者在随访结束时仍处于缓解状态，输注最早的两例患者无进展生存期达12.6个月；另外17例患者缓解后行巩固性造血干细胞移植（10例）或CD22 CAR-T细胞序贯治疗（7例），76.5%（13/17）的患者在随访结束时仍处于缓解状态；其余5例患者未接受巩固性治疗，在CAR-T细胞治疗后中位第72（55~115）天复发。1年总生存率为73.6%（95%CI 55.2%~92.3%），1年无进展生存率为56.2%（95%CI 38.1%~75.2%）。所有患者均发生了细胞因子释放综合征，63.4%（26/41）为1~2级。3例患者发生免疫效应细胞相关神经毒性综合征。 结论： 人源化靶向CD19 CAR-T细胞能有效诱导R/R B-ALL患者获得完全缓解，且不良反应可耐受。.
Keywords: Acute lymphoblastic leukemia acute; Chimeric antigen receptor T cell; Humanized; Refractory; Relapsed.