我们评估了同种异体体外扩增 NK 细胞 MG4101 在难治性或复发性 AML 患者中的安全性和有效性。分析免疫学特征与临床反应之间的关系。 2018年4月至2020年2月期间，11名患者（男性：女性= 5：6）接受了MG4101治疗。在八名可评估的患者中，两名（25.0%）显示部分缓解，两名（25.0%）显示疾病稳定。中位总生存期为 3.4 个月（95% 置信区间 [95% CI]，2.5-4.3 个月），同种异体造血干细胞移植 (HSCT) 审查的反应持续时间为 2.9 个月（95% CI，1.5-4.4 个月） ）。两名患者在 MG4101 治疗后接受了 HSCT。除一例3级输注相关反应外，未观察到严重不良事件。有反应者的激活 KIR 总和往往高于无反应者。 NKRL 和 KIR 的分析强调了免疫机制在治疗骨髓肿瘤中的重要性。

We evaluated the safety and efficacy of allogeneic, ex-vivo expanded, NK cells, MG4101, in patients with refractory or relapsed AML. The relationship between immunological characteristics and clinical responses was analyzed. Between April 2018 and February 2020, 11 patients (male:female = 5:6) were treated with MG4101. Of eight evaluable patients, two (25.0%) showed partial response and two (25.0%) showed stable disease. The median overall survival was 3.4 months (95% confidence interval [95% CI], 2.5-4.3 months), and the allogeneic hematopoietic stem cell transplantation (HSCT) censored duration of response was 2.9 months (95% CI, 1.5-4.4 months). Two patients underwent HSCT after MG4101 treatment. Except for one grade 3 infusion-related reaction, no serious adverse events were observed. The sum of activating KIRs in responders tended to be higher than that in non-responders. Analyses of NKRL and KIR highlighted the importance of immunological mechanisms in treating myeloid neoplasms.