Monitoring vital signs in patients with blood cancers undergoing CAR-T therapy
Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
This study is testing two new devices to see if they can help monitor vital signs in adults with blood cancers who are receiving CAR-T therapy, aiming to catch any treatment-related issues early and improve their health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | Blinatumomab, Mosunetuzumab, Talquetamab, Elranatamab, Teclistamab, Glofitamab, Epcoritamab, CAR-T, chimeric antigen receptor |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06415656 on ClinicalTrials.gov |
What this trial studies
This study evaluates two innovative vital sign monitoring devices, TempTraq and VitalTraq, in adults with hematologic malignancies receiving CAR-T or BiTE therapies. TempTraq is a wearable patch that continuously tracks body temperature, while VitalTraq is a smartphone app that uses facial scanning to estimate blood pressure, heart rate, heart rate variability, and respiratory rate. The goal is to enhance early detection and intervention for treatment-related toxicities, such as cytokine release syndrome (CRS) and febrile neutropenia, thereby improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hematologic malignancies undergoing specific CAR-T or BiTE therapies.
Not a fit: Patients receiving non-FDA approved CAR-T or BiTE products or those on Epcoritamab may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of serious treatment-related complications in patients with blood cancers.
How similar studies have performed: Other studies have shown promise in using remote monitoring technologies for early detection of complications in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke Blood Cancer Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Chenyu Lin, MD — Duke University
- Study coordinator: Lauren Hill
- Email: lauren.hill@duke.edu
- Phone: 9196682369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.