肿瘤细胞治疗研究
英文原题：Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
这是一项 I/II 期注册临床试验，评估 NK 细胞治疗急性髓系白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 20 例。试验地点：美国 · 辛辛那提（共 1 个中心）。登记号：NCT05580601。
不限性别 · ≥ 2 Years
纳入标准：入组时年龄≥2岁；按WHO 2016标准确诊AML；骨髓中存在复发或难治性AML；难治性疾病：强化诱导治疗2个疗程后骨髓原始细胞≥5%；复发性疾病：首次完全缓解（CR）后6个月内骨髓原始细胞≥5%或外周血再次出现原始细胞；有可用的半相合亲属供者，入组前或入组时对受者进行供者特异性抗体（DSA）检测；>16岁患者Karnofsky评分≥50%，≤16岁患者Lansky评分≥50%。排除标准：疾病情况为单纯CNS受累、单纯髓外病灶或急性早幼粒细胞白血病（APML）（骨髓合并髓外受累者可入组）；未控制活动性感染；超声心动图显示收缩射血分数<45%；室内空气血氧饱和度<92%；肝功能不全（总胆红素>2 mg/dL，AST或ALT>正常值上限3倍）；同时用药中强的松等效剂量>10 mg/日或>0.5 mg/kg/日（取较低者）；正在接受其他研究性治疗；已知对IL-2注射剂过敏或有超敏反应；妊娠或哺乳（因淋巴细胞清除化疗对胎儿有风险）。女性须进行妊娠试验；有生育能力的男性或女性须同意在研究治疗期间及完成后6个月使用有效避孕措施。避孕方式包括口服避孕药、贴剂或注射剂、宫内节育器、输卵管结扎、伴侣输精管结扎或禁欲。
Inclusion Criteria: * Of age ≥ 2 years of age at the time of study enrollment * With AML diagnosed per 2016 WHO criteria (11) * With relapsed or refractory AML in their bone marrow * Refractory disease: Patients must have ≥ 5% blasts in the bone marrow after 2 courses of intensive induction treatment * Relapsed disease: Patients must have ≥ 5% blasts in the bone marrow, or reappearance of blasts in the blood, within 6 months of initial CR * With available haploidentical related donors. Donor specific antibody (DSA) testing will be done on the recipient prior to or upon enrollment. * With performance level of ≥ 50% on Karnofsky scale for patients \> 16 years of age and ≥ 50% on Lansky scale for patients ≤ 16 years of age Exclusion Criteria: * Disease: isolated central nervous system (CNS) disease, or isolated extramedullary disease, or diagnosis of acute promyelocytic leukemia (APML). Patients with extramedullary disease in combination with bone marrow disease are eligible for enrollment. * Infectious Disease: Active uncontrolled infection * Cardiac function: Systolic ejection fraction \<45% by echocardiogram * Pulmonary Function: Oxygen saturation \<92% on room air * Hepatic function: Total bilirubin \> 2mg/dL, AST and ALT more than three times the upper limit of normal * Concomitant medications: receiving either \>10mg prednisone equivalent daily, or \>0.5mg/kg prednisone equivalent daily, whichever is less * Concomitant investigational treatments: receiving other investigational therapies * Known allergy or hypersensitivity reaction to IL-2 injections * Pregnant or breastfeeding women will not be entered on this study due to risks of fetal and teratogenic adverse events with lymphodepleting chemotherapy. Pregnancy tests must be obtained for female patients. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion. Effective contraceptive methods include oral contraceptive pills, patches, or injections, intrauterine devices, having a tubal ligation, having a partner who has had a vasectomy, or not having sex.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Feasibility of infusion · Number of patients who receive CIML-NK infusion without grade 3-4 infusional toxicity events as assessed by CTCAE v5.0 divided by the number of patients enrolled. · 30 days
次要终点：Clinical Response to CIML-NK Infusion；Persistence of CIML-NK cells in the recipients' peripheral blood；Proceed to Hematopoietic Stem Cell Transplant (HSCT)
研究性细胞产品为从受者半相合供者白细胞单采产品制备的细胞因子诱导记忆样NK细胞。
本研究旨在证明可从供者细胞制备细胞因子诱导记忆样自然杀伤细胞（CIML-NK），并安全输注给复发或难治性急性髓系白血病（AML）患者。次要目标是评估CIML-NK细胞治疗AML的疗效。
The objective of this study is to demonstrate that cytokine-induced memory-like natural killer cells can be generated from donor cells and infused safely into patients with relapsed or refractory acute myeloid leukemia (AML). A secondary objective is to assess efficacy of the CIML-NK cells in treating AML.
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