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临床试验 NCT07499128 针对细胞因子释放综合征，肿瘤，淋巴瘤，前体细胞淋巴母细胞白血病-淋巴瘤，多发性骨髓瘤，套细胞淋巴瘤，免疫治疗，Cell and Tissue-Based Therapy，细胞因子，生理监测，Immune Monitoring，Wearable Electronic Devices，Thermometry，体温，Antibodies Bispecific，Receptors Chimeric Antigen目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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国家癌症研究所Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event 136
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临床试验NCT07499128是一项针对细胞因子释放综合征，肿瘤，淋巴瘤，前体细胞淋巴母细胞白血病-淋巴瘤，多发性骨髓瘤，套细胞淋巴瘤，免疫治疗，Cell and Tissue-Based Therapy，细胞因子，生理监测，Immune Monitoring，Wearable Electronic Devices，Thermometry，体温，Antibodies Bispecific，Receptors Chimeric Antigen的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年4月5日开始，预计招募136名患者。该研究由国家癌症研究所主导，计划于2029年8月18日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月31日。
简要概括
Background:
Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems. Researchers want to know if continuously monitoring a person s body temperature can help reduce the chance of g...
显示更多详细描述
Background:
- Cellular therapy and cellular engager-based immunotherapy treatments, including but not limited to Chimeric Antigen Receptor (CAR) T-cell and bispecific T-cell engagers (BiTE), have an adverse event profile that often involves Grade >= 3 Cytokine Release Syndrome (CRS).
- As a sequela of activating the immune system to engage their underlying cancer, CRS symptoms can range from grade 1 (e.g., fever am...
官方标题
Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event
疾病
细胞因子释放综合征肿瘤淋巴瘤前体细胞淋巴母细胞白血病-淋巴瘤多发性骨髓瘤套细胞淋巴瘤免疫治疗Cell and Tissue-Based Therapy细胞因子生理监测Immune MonitoringWearable Electronic DevicesThermometry体温Antibodies BispecificReceptors Chimeric Antigen其他研究标识符
- 10002457
- 002457-C
NCT编号
实际开始日期
2026-04-05
最近更新发布
2026-03-31
预计完成日期
2029-08-18
计划入组人数
136
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Cytokine Release Syndrome
Continuous Temperature Monitoring
Wearable Device
TempTraq
Digital Oncology
VitalTraq
CRS Management
Fever Detection
Immunotherapy Toxicity
Bispecific T-cell Engager
Continuous Temperature Monitoring
Wearable Device
TempTraq
Digital Oncology
VitalTraq
CRS Management
Fever Detection
Immunotherapy Toxicity
Bispecific T-cell Engager
主要目的
医疗器械可行性
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预Control Arm 2 Use of non-readable CTM devices, TempTraq without actionable alerts, and optional use of black-boxed VitalTraq | 不适用 |
实验性Intervention Arm 1 Use of non-readable CTM devices, TempTraq with actionable alerts, and optional use of black-boxed VitalTraq | TempTraq Continuous temperature monitoring (CTM) wearable patch device VitalTraq Multi-vital, multi-sensor smartphone/ tablet application allowing data collection of blood pressure, heart rate, heart rate variability, and respiration rate using Remote Photoplethysmography technology (rPPG) |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
To assess whether continuous observations of fevers with TempTraq versus intermittent fevers monitoring reduce the risk of progression to grade >= 3 cytokine release syndrome (CRS) | Posterior means of the CRS severe adverse event per arm will be reported, along with the corresponding 95% credible intervals in the highest density interval (HDI) based on the corresponding posterior distributions | TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduce the duration of CRS episodes | Posterior probability of at least 3% absolute risk reduction may be evaluated by two different stratification factors considered at randomization, separately, if applicable, with sufficient numbers of evaluable participants within the corresponding sub-populations | TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment |
To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduces the escalation of CRS care | Posterior probability of at least 3% absolute risk reduction may be evaluated by two different stratification factors considered at randomization, separately, if applicable, with sufficient numbers of evaluable participants within the corresponding sub-populations | TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Age >= 18 years.
- Participants must be enrolled in an active treatment protocol at NIH utilizing cellular therapy, cellular engagers, or other novel monotherapy or combination immunotherapy agents associated with a known or anticipated risk profile for grade >= 3 cytokine release syndrome (CRS) adverse effects.
- Participants must be receiving immunotherapy dose(s) and be admitted to the Clinical Center. Note: Enrollment during the first week of treatment on an active treatment protocol, when CRS risk is highest, is preferable, but starting later during their active treatment course is acceptable.
- Ability of the participant to understand and the willingness to sign a written informed consent document.
- Prior solid organ or stem cell transplantation on active immunosuppression.
- Regimen including antibiotics, for documented active infection within 7 days prior to study enrollment.
- Current syndrome associated with cyclic fevers.
- History of severe drug allergies, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
- Known current alcohol use disorder or drug use disorder that, in the opinion of the investigator, would interfere with the participant s ability to comply with study procedures or safely participate in the study.
国家癌症研究所研究中心联系人
联系人: Karen C Kwok, C.R.N.P., (240) 620-0858, [email protected]
联系人: Nicholas P Tschernia, M.D., (240) 506-3532, [email protected]
1 位于 1 个国家/地区的研究中心
Maryland
National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States
National Cancer Institute Referral Office, 联系人, 888-624-1937, [email protected]