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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Device: TempTraq; Device: VitalTraq

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Hill; Phone Number: 7045774113; Email: lauren9494@gmail.com
• Study Contact Backup: Name: Chenyu Lin, MD; Phone Number: +1 919 684 8964; Email: chenyu.lin@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
   • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with hematologic malignancies; Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.

Device: TempTraq; TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.; Device: VitalTraq; VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TempTraq's ability to measure axillary temperature in the intended use population.	Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements.	The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature > 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers.	Day 14
VitalTraq's ability to measure blood pressure in the intended use population.	Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively.	Day 14
VitalTraq's ability to measure heart rate in the intended use population.	Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute.	Day 14
Patient's perspective on the burden of using TempTraq and VitalTraq.	The mean scores on individual questions in a post-intervention survey featuring 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree, will be calculated and described. A lower score indicates lower burden.	Day 28
Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care.	The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring.	Day 14

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Blue Spark Technologies
• Investigators: Principal Investigator: Chenyu Lin, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: Pro00115012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No