Objective: To investigate the outcomes of anti-CD19 CAR-T cell for relapsed and refractory B cell malignancies. Method: Ten patients with relapsed and refractory B cell acute lymphocytic leukemia (B-ALL) and non-Hodgkin's lymphoma (NHL), diagnosed in the Department of Hematology of Peking University third Hospital from December 2015 to July 2017, were treated with anti-CD19 CAR-T cell therapy, and the efficacy and safety were analyzed. Results: Efficacy was assessed on the 28th day after cell infusion, including 66.7% (4/6) of complete remission (CR) for patients with ALL, 16.7% (1/6) of partial remission (PR), and 83.3% (5/6) of overall response rate (ORR). For NHL patients, CR was 33.3% (1/3) and most of the lesions disappeared in a patient with mantle cell lymphoma, but residual lesion presented persistent state. After infusion of anti-CD19 CAR-T cells, the main side effect was cytokine release syndrome (CRS) and fever. One patient presented with aphasia and the other one had multiple organ failure, which were improved after treatment. No patients died of CRS. Conclusion: anti-CD19 CAR-T cell for relapsed and refractory B cells hematological malignancies is safe, and the most problematic side effect is CRS, which can be controlled by therapy.
目的： 探讨抗CD19 CAR-T细胞治疗难治复发B细胞肿瘤的疗效和不良反应。 方法： 2015年12月至2017年7月北京大学第三医院血液科收治的10例患者，包括难治复发的急性B淋巴细胞白血病（B-ALL）6例，难治复发的B细胞非霍奇金淋巴瘤（NHL）4例，采用抗CD19 CAR-T细胞治疗后观察治疗效果及不良反应。 结果： 输注后第28天进行近期疗效评估，其中6例ALL患者4例（66.7%）完全缓解（CR），1例（16.7%）部分缓解（PR）；总反应率（ORR）为83.3%。3例弥漫大B细胞淋巴瘤（DLBCL）患者1例达CR。1例套细胞淋巴瘤（MCL）患者大部分病灶消失，亦有顽固病灶呈进展状态。10例患者均发生细胞因子释放综合征（CRS），主要表现为发热；其中1例患者出现中枢神经系统症状，1例患者出现多脏器功能衰竭，经治疗不良反应均治愈。 结论： 抗CD19 CAR-T细胞治疗难治复发B细胞血液系统肿瘤有效，不良反应可控。.
Keywords: Anti-CD19 CAR-T cell; B cell hematological malignancies; Treatment outcomes.