NCT07911540Not yet recruiting
A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Multiple myeloma
- NCT number
- NCT07911540
What you commit to
- Study type: Interventional
- Planned participants: 105
- From 1 Dec 2026 to the primary completion date, 1 Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of silicone allergy
- History of Medical Adhesive-Related Skin Injury (MARSI)
- Known skin condition that might preclude safe application of the patch, in the opinion of the enrolling investigator
- Provider/Staff:
- None
Other
- Patients:
- Planned prophylactic tocilizumab for mitigation of CRS as documented in the clinical trials pathway submission
Who the study is looking for
- Patients:
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥ 18 years at the time of consent
- Scheduled to undergo CAR-T therapy in the outpatient setting at AHWFBCCC
- Ability to read and understand the English and/or Spanish language
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
- Access to a mobile device for the duration of the trial
- Provider/Staff:
- Provider/staff participants must meet all of the following inclusion criteria to participate in the study:
- Verbally agree to participate
- Hospital at Home outpatient provider/advanced practice provider/nurse of at least one patient participant enrolled on Arm A who completed 14 days of temperature monitoring
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atrium Health Levine Cancer Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.