Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Monitoring heart rate data
研究概览
简要总结
The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of adverse events including Cytokine Release Syndrome and neurotoxicity.
Our study aims are to improved early detection and precise management of adverse events for patients receiving Chimeric antigen receptor T- cell (CAR-T):
- To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
- To generate comprehensive multiomic profile analysis following CAR-T therapy.
- To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participant must be in the process of undergoing cancer cell therapy at Stanford University.
- •Adults > 18 years
- •Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.)
- •English speaking
- •Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection
排除标准
- •In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.
结局指标
主要结局
Monitoring heart rate data
时间窗: 28 days
Defined as ≥70% of patients able to wear at least one sensor device for ≥50% of the days from CAR-T infusion (Day 0) to Day 28. Each day is counted if ≥12 hours of data are captured.
Monitoring temperature data
时间窗: 28 days
Proportion of patients able to wear at least one sensor device for ≥50% of days from Day 0 (CAR-T infusion) through Day 28, with ≥12 hours/day of usable data collected (temperature, heart rate).
次要结局
- Feasibility of microsampling(28 days)
- Safety of wearable devices(28 days)
- Safety of the microsampling device(28 days)
研究者
Surbhi Sidana, MD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Stanford University