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Can a smart patch predict dangerous immune reactions in cancer treatment?

NCT ID NCT07499128

Knowledge-focused Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a wearable patch called TempTraq can detect fevers earlier than standard temperature checks in cancer patients receiving immunotherapy. The goal is to see if continuous monitoring reduces the risk of severe cytokine release syndrome (CRS), a serious side effect. About 136 adults with cancer will wear the patch for up to 15 days while in the hospital. Some may also use a smartphone app to measure vital signs. The study is observational and does not provide a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TempTraq wearable patch and VitalTraq app
What this could lead to
If successful, this could lead to earlier detection of fevers from cytokine release syndrome, potentially reducing severe complications in cancer patients receiving immunotherapy.
What could go wrong
This is an early-stage observational study with only 136 participants, so results may not apply to all patients. The patch monitors temperature but does not prevent CRS, and its benefit over standard care is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

cancer cytokine release syndrome lymphoma mantle cell lymphoma neoplasm plasma cell myeloma Precursor Cell Lymphoblastic Leukemia-Lymphoma precursor lymphoblastic lymphoma/leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibodies bispecific Body temperature Cell and tissue-based therapy Cytokine release syndrome Cytokines Immune monitoring Immunotherapy Lymphoma Lymphoma, mantle cell Monitoring, physiologic Multiple myeloma Neoplasms Precursor cell lymphoblastic leukemia-lymphoma Receptors chimeric antigen Thermometry Wearable electronic devices

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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