A Safety/Feasibility Trial of the Addition of the Humanized Anti-GD2 Antibody (hu14.18K322A) With and Without Natural Killer Cells to Chemotherapy in Children and Adolescents With Recurrent/Refractory Neuroblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of patients experiencing unacceptable toxicity associated with humanized anti-GD2 antibody/chemotherapy (course 1) and anti-GD2 antibody/chemotherapy/NK cells (course 2).
研究概览
简要总结
This is a safety / feasibility trial evaluating the combination of a humanized anti-GD2 antibody (HU14.18K322A) manufactured at the Children's GMP, LLC at St. Jude with allogeneic natural killer (NK) cells and standard chemotherapy in children with relapsed or refractory neuroblastoma.
详细描述
Eligible participants will receive chemotherapy combined with Hu14.18K322A antibody daily for four consecutive days. Those participants who go on to receive the second course of chemotherapy with Hu14.18K322A will receive an infusion of allogeneic NK cells after the 4th dose of Hu14.18K322A antibody. A maximum of six courses will be given.
Primary Objective:
- To observe and describe the toxicities associated with humanized anti-GD2 antibody (hu14.18K322A) with and without allogeneic NK cells when given with repeated cycles of chemotherapy to children with refractory/relapsed neuroblastoma.
Secondary Objective:
- To describe response, time to progression, event-free and overall survival.
- To evaluate the feasibility of administering NK cells from a suitable donor after completion of the last dose of hu14.18K322A in three repeated cycles of chemotherapy
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
Participants receive humanized anti-GD2 antibody, chemotherapy, cytokines, and natural killer cells.
Cells for infusion are prepared using the CliniMACS System.
干预措施: Humanized anti-GD2 antibody (Biological)
Treatment
Participants receive humanized anti-GD2 antibody, chemotherapy, cytokines, and natural killer cells.
Cells for infusion are prepared using the CliniMACS System.
干预措施: Chemotherapy (Drug)
Treatment
Participants receive humanized anti-GD2 antibody, chemotherapy, cytokines, and natural killer cells.
Cells for infusion are prepared using the CliniMACS System.
干预措施: Cytokines (Other)
Treatment
Participants receive humanized anti-GD2 antibody, chemotherapy, cytokines, and natural killer cells.
Cells for infusion are prepared using the CliniMACS System.
干预措施: Natural killer cells (Biological)
Treatment
Participants receive humanized anti-GD2 antibody, chemotherapy, cytokines, and natural killer cells.
Cells for infusion are prepared using the CliniMACS System.
干预措施: CliniMACS (Device)
结局指标
主要结局
Number of patients experiencing unacceptable toxicity associated with humanized anti-GD2 antibody/chemotherapy (course 1) and anti-GD2 antibody/chemotherapy/NK cells (course 2).
时间窗: First two courses of treatment (42 days)
Unacceptable toxicities are defined as: 1) any grade 4 toxicity that does not return to baseline by day 35, 2) any toxicity requiring the use of pressors, including grade 4 acute capillary leak syndrome or grade 3 or 4 hypotension, 3) any toxicity requiring ventilation support, including grade 4 respiratory toxicity, 4) grade 4 neutropenia or thrombocytopenia lasting \> 35 days (only during course 2), and 5) death from toxicity.
次要结局
- Time to progression.(Time from date of study enrollment to date of disease progression or recurrence, assessed up to 4.5 years.)
- Response to treatment(Baseline and three (3) weeks following courses 2, 4, and 6)
- Event free survival.(Time from date of study enrollment to date of first event (relapsed or progressive disease, second malignancy or death from any cause) or to the date of last contact for patients without events, assessed up to 4.5 years.)
- Overall survival(Time from date of study enrollment to date of death from any cause or to the date of last contact for survivors, assessed up to 4.5 years.)