Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event

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 getting serious CRS.

Objective:

To learn if an approved patch called TempTraq can detect fever before serious CRS develops.

Eligibility:

People aged 18 years and older with cancer who are staying at the NIH clinic for treatment with drugs or cell therapies.

Design:

Participants will receive TempTraq patches and a special NIH tablet. The TempTraq is a small patch applied to clean, dry skin under the arm. It continually monitors body temperature and sends the data to an application on the tablet.

Participants will wear the patch most of the time they are admitted to the hospital. They could wear it for up to 15 days. The patch monitoring does not replace regular temperature checks, all participants will still have have their regular temperature checks as part of their treatment plan.

Participants may also opt to use VitalTraq, another application on the tablet. They will hold the screen up to their face for about 1 minute. VitalTraq uses the camera in the tablet to measure blood pressure, heart rate, and breathing. They will do this once per day while they are in the clinic; they may do it more often if they have a fever or feel unwell.

Blood may be drawn for research.

Participants will be asked about their experience within 1 week after TempTraq is removed. Participants who choose to use the patch, complete its use, and return at a later date for another treatment or study, may be able to re-enroll to have the patch used again.

Study Overview

• Status: Enrolling by invitation
• Conditions: Neoplasms; Lymphoma; Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Cytokine Release Syndrome; Cytokines; Immunotherapy; Body Temperature; Wearable Electronic Devices; Thermometry; Lymphoma Mantle-cell; Cell and Tissue-Based Therapy; Monitoring Physiologic; Immune Monitoring; Antibodies Bispecific; Receptors Chimeric Antigen
• Intervention / Treatment: Device: TempTraq; Device: VitalTraq

Detailed Description

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 amenable to supportive care with antipyretics) to grade 4 (e.g., multiorgan failure requiring hospital admission for advanced vasopressor and ventilator support), even proceeding to death in severe cases.
• The symptoms of CRS can escalate over time, but early detection with accelerated intervention has been shown to avert high-grade CRS and more serious complications.
• A prompt CRS diagnosis shortens the treatment window for targeted interventions. Such as tocilizumab, a monoclonal antibody that blocks the interleukin (IL)-6 receptor, or systemic corticosteroids. Agents that can mitigate CRS from progressing to more severe grades, decrease the need for Intensive Care Unit (ICU) management, and could potentially redefine CRS monitoring using an outpatient management algorithm.
• TempTraq is a Food and Drug Administration (FDA)-cleared continuous temperature monitoring (CTM) wearable patch device. Compared with intermittent temperature monitoring used in Standard of Care (SOC) practice, this CTM approach has been shown to detect fevers earlier by a median of 4.9 hours.
• VitalTraq is a 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). The VitalTraq application involves a viscerocranial capillary scan, whereby a camera scans the small blood vessels of the face for 30-60 seconds. VitalTraq has not yet been FDA-cleared.

Objective:

-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)

Eligibility:

• Age >= 18 years
• Histologically or cytologically proven cancer
• Receiving cellular therapy, cellular engagers, or other novel monotherapy or combination immunotherapy agents associated with a known or anticipated risk profile for grade >= 3 CRS at NIH

Design:

• After enrollment, participants will be randomized to Arm 1 or Arm 2. Participants in Arm 1 will get a non-readable Continuous Temperature Monitoring (CTM) TempTraq wearable device WITH actionable alerts, and participants in Arm 2 will get a non-readable CTM TempTraq wearable device WITHOUT actionable alerts.
• All participants will continue to be monitored for vital signs per the treatment protocols they are enrolled in.
• For the Intervention Arm 1 only, the assigned nurse will receive alerts set for temperature data that reaches and/or exceeds a threshold above 100.4 degrees Fahrenheit on their designated clinic smartphone. With a temperature alert from the device, nursing staff would be expected to reassess the participant and to evaluate vital signs with the Unit s standard device thermometer within one hour of the initial threshold alert.
• Temperature data from the standardized devices and TempTraq will hold equivalent primacy per clinician discretion, as well as activation of the procedures outlined in the participant s primary treatment protocol.
• The post-hoc analysis includes a chart review of medical history and clinical course with adjudication of febrile etiology, either related to CRS alone or likely related to CRS. For the temperature readings obtained from CTM TempTraq and the standard device used in the Clinical Center, the chart review will compare time of fever detection, diagnosis of CRS, initiation of CRS interventions, incidence of CRS complications with use of supportive care, and duration of CRS episode.
• We will also evaluate additional markers predictive of progression to grade >= 3 CRS (e.g., monitoring with VitalTraq, demographics, performance status, treatment history, hematologic biomarkers).

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• INCLUSION CRITERIA:
• 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.

EXCLUSION CRITERIA:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm 2; Use of non-readable CTM devices, TempTraq without actionable alerts, and optional use of black-boxed VitalTraq
Experimental: Intervention Arm 1; Use of non-readable CTM devices, TempTraq with actionable alerts, and optional use of black-boxed VitalTraq	Device: TempTraq; Continuous temperature monitoring (CTM) wearable patch device; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nicholas P Tschernia, M.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): August 18, 2029

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 27, 2026

More Information

Terms related to this study

• Keywords: Wearable Device; Cytokine Release Syndrome; Bispecific T-cell Engager; Continuous Temperature Monitoring; TempTraq; Digital Oncology; VitalTraq; CRS Management; Fever Detection; Immunotherapy Toxicity
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Leukemia; Shock; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Cytokine Release Syndrome; Neoplasms; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Multiple Myeloma; Lymphoma, Mantle-Cell
• Other Study ID Numbers: 10002457; 002457-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will comply with the NIH Data Management and Sharing (DMS) Policy, applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, which that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
• IPD Sharing Time Frame: Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
• IPD Sharing Access Criteria: Clinical data will be made available upon request and with the permission of the study Pl.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No