肿瘤细胞治疗研究
英文原题：A Clinical Trial on Autologous NK Cells Combined With GD2 Monoclonal Antibody in the Treatment of Children With Newly Diagnosed High-risk or Relapsed/Refractory Neuroblastoma
⚠ 该试验的登记信息已有 17 个月未更新， 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I/II 期注册临床试验，评估自体 NK 细胞治疗神经母细胞瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 15 例。登记号：NCT06948994。
不限性别 · ≥ 1 Year 且 ≤ 18 Years
纳入标准： 1. 年龄1～18岁（含18岁），性别不限。 2. 诊断为高危神经母细胞瘤，并符合以下任一情况：按COG、SIOPEN或专家共识CCCG-NB-2021接受包括诱导治疗和巩固治疗在内的规范治疗后进入维持治疗阶段；接受COG化疗联合GD2免疫治疗诱导后进入维持治疗阶段；规范治疗后发生任何复发；或初步判定为难治状态。 3. 复发／难治性神经母细胞瘤患者须至少有1个符合RECIST 1.1标准的可测量病灶。 4. 主要器官功能正常，符合以下标准： （1）血常规：血红蛋白≥80 g/L；中性粒细胞绝对计数（ANC）≥0.75×10⁹/L；血小板≥75×10⁹/L。 （2）血液生化：血清白蛋白≥28 g/L；总胆红素≤正常值上限（ULN）的2倍；天冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）≤ULN的3倍；碱性磷酸酶（ALP）≤ULN的3倍；肌酐≤ULN的1.5倍。 （3）凝血功能：国际标准化比值（INR）或凝血酶原时间（PT）≤ULN的1.5倍；活化部分凝血活酶时间（APTT）≤ULN的1.5倍。 （4）超声心动图显示心脏舒张功能正常，左心室射血分数（LVEF）≥50%，且无严重心律失常。 （5）无严重肺部或肾脏疾病，无活动性肺部感染；室内空气下血氧饱和度≥92%。 5. 预期生存期≥6个月。 6. 患者及监护人充分知情同意后签署知情同意书。 排除标准： 1. 存在未控制的活动性感染，或预计参加本试验期间需要接受全身抗感染或免疫抑制治疗。 2. 既往抗肿瘤治疗引起的任何毒性反应尚未恢复至≤1级（CTCAE 5.0版）；脱发除外。 3. 有器官移植史，或预计试验期间将接受器官移植。 4. 属于高度过敏体质。 5. HIV感染。 6. 研究者认为不适合参加本研究的其他情况。
Inclusion Criteria: 1. Age 1-18 years (including 18 years), gender not restricted; 2. Diagnosed with high-risk neuroblastoma and meeting the following conditions: high-risk neuroblastoma has undergone standardized treatment including induction therapy and consolidation therapy according to COG, SIOPEN or the expert consensus CCCG-NB-2021, and has entered the maintenance stage; high-risk neuroblastoma has undergone induction therapy with COG chemotherapy combined with GD2 immunotherapy and has entered the maintenance stage; any recurrence of high-risk neuroblastoma after standardized treatment; or the disease is initially determined to be in a refractory state. 3. If it is relapsed/refractory neuroblastoma, there must be at least one measurable lesion according to RECIST 1.1 criteria; 4. Normal major organ function, that is, meeting the following standards: (1) Blood routine test: hemoglobin \>= 80 g/L; absolute neutrophil count (ANC) \>=0.75×10\^9/L; platelet count \>= 75×10\^9/L; (2) Blood biochemistry test: serum albumin \>=28 g/L; total bilirubin \<= 2×upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT) \<= 3×ULN; alkaline phosphatase (ALP) \<= 3×ULN; creatinine \<= 1.5×ULN; (3) Coagulation function: international normalized ratio (INR) or prothrombin time (PT) \<= 1.5×ULN; activated partial thromboplastin time (APTT)\<=1.5×ULN; (4) Echocardiogram shows normal diastolic function of the heart, left ventricular ejection fraction (LVEF) \>= 50%, and no severe arrhythmia; (5) No severe lung or kidney disease, no active pulmonary infection. Indoor air oxygen saturation \>=92%; 5. Expected survival time \>= 6 months; 6. After obtaining full informed consent from the patient and guardian, sign the informed consent form. Exclusion Criteria: 1. Uncontrollable active infections, or expected to receive systemic anti-infection or immunosuppressive therapy during participation in this trial; 2. Any toxic reactions caused by previous anti-tumor treatments have not recovered to grade 1 or below (CTCAE 5.0 version) (hair loss is not restricted); 3. Have a history of organ transplantation or are expected to undergo organ transplantation during the trial period; 4. Highly allergic constitution; 5. HIV infection; 6. The researchers believe that there are other circumstances in which the subjects are not suitable to participate in this study.
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：adverse event · during the treatment phase；serious adverse event · during the treatment phase；overall survival · 3 years；event-free survival · 3 years
次要终点：progression-free survival
采用自体NK细胞联合GD2单克隆抗体治疗。
这是一项前瞻性、单臂、开放标签、单中心临床试验，旨在评估自体NK细胞联合化疗和GD2单克隆抗体治疗儿童新诊断高危或复发／难治性神经母细胞瘤的安全性和疗效。计划纳入15例符合条件的受试者。研究目标是评估该联合治疗的安全性和疗效，预计其可提高难治／复发性神经母细胞瘤患儿的无进展生存期（PFS）和疾病控制率（DCR）。
This is a prospective, single-arm, open, single-center clinical trial to evaluate the safety and efficacy of autologous NK cells combined with chemotherapy and GD2 monoclonal antibody in the treatment of newly diagnosed high-risk or relapsed/refractory neuroblastoma in children. Fifteen eligible subjects are planned to be included. The objective is to evaluate the safety and efficacy of autologous NK cells combined with GD2 monoclonal antibody in the treatment of children with newly diagnosed high-risk or relapsed/refractory neuroblastoma, which is expected to be safe and effective in improving PFS and DCR in children with refractory/recurrent neuroblastoma.
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