A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Specific Chimeric Antigen Receptor (CAR) T Cells
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities
研究概览
简要总结
This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (age >/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study
排除标准
- •Patients with uncontrolled systemic fungal and bacterial infections
- •Patients with known hypersensitivity to E. coli-derived proteins
- •Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Arm 1 (CART Cell Group)
Cohort 1 Patients will receive anakinra 100mg s.c. every 12 hours starting on day 2 post CAR T cell infusion, or after 2 documented fevers of ≥38.5° C prior to day 2, whichever time point is earlier. Anakinra will be continued for 10 days.
Cohort 2 Patients will receive anakinra 100mg s.c. daily on day 0 of T cell infusion, and continue anakinra daily for 7 days
干预措施: Anakinra (Drug)
结局指标
主要结局
Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities
时间窗: 4 weeks
Determine the rate of severe neurotoxicities, \>/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells
Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation
时间窗: 28 days from the start of treatment
proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment.
次要结局
未报告次要终点