Clinical trial · Interventional
VitalTraq for the Detection of CRS
Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TempTraq | Device | — | UNRESOLVED |
| VitalTraq | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with hematologic malignancies
- description
- Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
- interventionNames
- Device: TempTraq
- Device: VitalTraq
Primary outcomes (1)
- measure
- TempTraq's Ability to Measure Axillary Temperature in the Intended Use Population
- timeFrame
- Day 14
- description
- Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers).
Secondary outcomes (5)
- measure
- Lead Time by Which Fevers Can be Detected Using TempTraq Compared to SOC Interval Oral Thermometer Measurements
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows: * Axicabtagene ciloleucel * Lisocabtagene maraleucel * Brexucabtagene autoleucel * Idecabtagene vicleucel * Ciltacabtagene autoleucel * Obecabtagene autoleucel * Tisagenlecleucel * Blinatumomab * Mosunetuzumab * Talquetamab * Elranatamab * Teclistamab * Glofitamab 2. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening. 3. Able to read and understand English 4. Willing and able to provide informed consent to the study Exclusion Criteria: 1. Receiving a non-FDA approved CAR-T or BiTE product 2. Receiving Epcoritamab
References
Publications (0)
Data not yet available