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Continuous Temperature Monitoring for Cytokine Release Syndrome (CRS)

This study is looking at whether continuous temperature monitoring can help prevent serious cytokine release syndrome (CRS) in people with cancer. CRS is a side effect of some cancer treatments, like cellular therapy or immunotherapy, where the body makes too many immune proteins called cytokines, causing symptoms like fever. Researchers want to see if using a wearable patch called TempTraq, which continuously checks your temperature, can detect fevers early. This could help doctors intervene sooner and reduce the risk of CRS becoming severe. You can join if you are 18 or older, have cancer, and are receiving certain treatments at the NIH clinic. The study aims to see if continuous temperature monitoring reduces the risk of developing severe CRS (grade 3 or higher). The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 136 participants. It is not specified if the study is randomized or blinded.
What's involved
You will wear a TempTraq patch for up to 15 days while in the hospital. You will also use a special NIH tablet to collect other vital sign data.
Compensation
Not stated in the trial record.
Follow-up
Monitoring for CRS symptoms will continue for a total of 2 months after you enroll in the study.

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NCT07499128

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

Enrolling by Invitation
NAAges 18+InterventionalDevice feasibility
National Cancer Institute (NCI)
~136 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:TempTraqVitalTraq

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment

Conditions

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

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LymphomaMantle Cell LymphomaMultiple MyelomaNeoplasmPrecursor cell lymphoblastic leukemia

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Nicholas P Tschernia, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

    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