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

NCT07499128 | Enrolling By Invitation

• 2 other identifiers: 10002457002457-C
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunotherapy; Cytokines; Cytokine Release Syndrome; Thermometry; Receptors Chimeric Antigen; Neoplasms; Lymphoma; Cell and Tissue-Based Therapy; Wearable Electronic Devices; Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma Mantle-cell; Monitoring Physiologic; Immune Monitoring; Body Temperature; Antibodies Bispecific

Keywords

Cytokine Release Syndrome; Continuous Temperature Monitoring; Wearable Device; TempTraq; Digital Oncology; VitalTraq; CRS Management; Fever Detection; Immunotherapy Toxicity; Bispecific T-cell Engager

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduce the duration of CRS episodes

  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

  TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment

Study Arms (2)

Control Arm 2

NO INTERVENTION

Use of non-readable CTM devices, TempTraq without actionable alerts, and optional use of black-boxed VitalTraq

Intervention Arm 1

EXPERIMENTAL

Use of non-readable CTM devices, TempTraq with actionable alerts, and optional use of black-boxed VitalTraq

Device: TempTraq; Device: VitalTraq

Interventions

VitalTraq DEVICE

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)

Intervention Arm 1

TempTraq DEVICE

Continuous temperature monitoring (CTM) wearable patch device

Intervention Arm 1

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cytokine Release Syndrome; Neoplasms; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Multiple Myeloma; Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoma, Non-Hodgkin

Study Officials

• Nicholas P Tschernia, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: March 30, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): August 18, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05-27

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Clinical data will be made available upon request and with the permission of the study Pl.

Locations

US (1)