一种称为同种异体 NK 细胞输注的新型免疫细胞移植被提议作为一种潜在的通用现成细胞产品，用于血液恶性肿瘤过继性免疫细胞治疗。进行了一项多中心 I 期非随机临床试验来评估其安全性，难治性/复发性 AML 患者过继输注 NK 细胞的可行性和潜在疗效。我们通过考虑细胞生产、患者选择和治疗方案来评估该试验的可行性。同种异体 NK 细胞是从随机的健康无关供体中产生的；根据纳入标准选择 10 名患者，并在 NK 细胞剂量递增的情况下分为两组。在第一次输注前 ​​7 天施用氟达拉滨-内毒素的淋巴细胞清除调理方案后，进行了两次细胞输注，间隔 7 天。根据细胞输注导致的生命体征变化，使用不良事件通用术语标准 (CTCAE) 对干预安全性进行评分。 NK 细胞嵌合、肿瘤负荷和复发持续时间被认为是疗效的组成部分。使用 CONSORT 平台检查试点可行性评估。NK 细胞输注程序耐受性良好，未观察到与 PB-NK 细胞输注相关（可能或可能）的 2-5 级毒性。 4 名患者在每次 PB-NK 细胞输注后出现 1 级短暂性寒战、头痛、呕吐和骨痛，无需住院治疗。其中一名患者 (p01) 因严重急性呼吸道综合症死亡。在 9 名可评估的患者中，6 名 (66.6%) 表现出疾病稳定 (SD)，3 名 (33.3%) 表现出疾病进展 (PD)。在 6 名 SD 患者中，2 名（p08 和 p09）在 SD 中仍存活，3 名患者（p04、p05 和 p07）在输注 NK 细胞后 9 个月转变为 PD，1 名（p03）由于随访而无法评估损失。没有患者达到完全缓解。该研究证明了在难治性/复发性 AML 患者中过继转移随机健康无关供体 PB-NK 细胞的可行性和安全性，并支持在复发性/难治性 AML 患者中继续进行 II 期临床试验。© 2023。作者。

A new type of immune cell transplantation called allogeneic NK cell infusion is proposed as a potential universal off-the-shelf cell product for adoptive immune cell therapy in hematologic malignancies.A multicentral phase I non-randomized clinical trial was conducted to assess the safety, feasibility, and potential efficacy of adoptively infused NK cells in patients with refractory/relapsed AML. We evaluated the feasibility of the trial by considering cell production, patient selection, and treatment protocol.Allogeneic NK cells were produced from random healthy unrelated donors; 10 patients were selected according to the inclusion criteria and were included in two groups in case of NK cell dose escalation. Two cell infusions were given, spaced 7 days apart, following a lymphodepletion conditioning regimen of fludarabin-endoxan administered 7 days before the first infusion. The intervention safety was scored using Common Terminology Criteria for Adverse Events (CTCAE) based on variations in vital signs due to cell infusion. NK cell chimerism, tumor burden, and duration of relapse were considered to be components of efficacy. The pilot feasibility evaluation was checked using the CONSORT platform.The NK cell infusion procedure was well tolerated, and no grade 2-5 toxicities related (possible or probable) to PB-NK cell infusion were observed. Four patients developed grade 1 transient chills, headaches, vomiting, and bone pain following each PB-NK cell infusion that were not required hospitalization. One of these patients (p01) died because of severe acute respiratory syndrome. Of 9 evaluable patients, 6 (66.6%) showed stable disease (SD) and 3 (33.3%) presented progressive disease (PD). Of 6 SD patients, 2 (p08 and p09) remained alive in SD and 3 patients (p04, p05 and p07) converted to PD at 9 months after infusion of NK cells, and 1 (p03) was not evaluable due to follow-up loss. No patient achieved complete remission.The study demonstrated the feasibility and safety of adoptive transfer of random healthy unrelated donor PB-NK cells in refractory/relapsed AML patients and supports continued study in phase II clinical trials in relapsed/refractory AML patients.© 2023. The Author(s).