NCT06948994尚未招募1 期
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
Guangzhou Women and Children's Medical Center0 个研究点目标入组 15 人开始时间: 2025年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- adverse event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-18 years (including 18 years), gender not restricted;
- •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.
- •If it is relapsed/refractory neuroblastoma, there must be at least one measurable lesion according to RECIST 1.1 criteria;
- •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%;
- •Expected survival time >= 6 months;
- •After obtaining full informed consent from the patient and guardian, sign the informed consent form.
排除标准
- •Uncontrollable active infections, or expected to receive systemic anti-infection or immunosuppressive therapy during participation in this trial;
- •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);
- •Have a history of organ transplantation or are expected to undergo organ transplantation during the trial period;
- •Highly allergic constitution;
- •HIV infection;
- •The researchers believe that there are other circumstances in which the subjects are not suitable to participate in this study.
结局指标
主要结局
adverse event
时间窗: during the treatment phase
serious adverse event
时间窗: during the treatment phase
overall survival
时间窗: 3 years
event-free survival
时间窗: 3 years
次要结局
- progression-free survival(3 years)
研究者
相似试验
撤回
早期 1 期
An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor PatientsSolid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer)NCT06284226Beijing Kejing Biotechnology Co., Ltd.
招募中
早期 1 期
Safety and Efficacy of Allogenic NK Cells in Combination With Chemotherapy in the Treatment of r/r AML After Allo-HSCTAcute Myeloid LeukemiaNCT05744440Xuzhou Medical University12
招募中
1 期
NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus NephritisRefractory Systemic Lupus ErythematosusRefractory Lupus NephritisNCT06676631Guangdong Provincial People's Hospital18
招募中
1 期
Autologous Natural Killer Cell Therapy for Hepatocellular CarcinomaHepatocellular CarcinomaNCT06044506Dr Cipto Mangunkusumo General Hospital3
招募中
2 期
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor TherapyHepatocellular CarcinomaNCT05962450Beijing YouAn Hospital84