Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events

The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of adverse events including Cytokine Release Syndrome and neurotoxicity.

Our study aims are to improved early detection and precise management of adverse events for patients receiving Chimeric antigen receptor T- cell (CAR-T):

1. To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
2. To generate comprehensive multiomic profile analysis following CAR-T therapy.
3. To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.

Study Overview

• Status: Completed
• Conditions: Leukemia; Multiple Myeloma; Hodgkin Lymphoma; Non Hodgkin Lymphoma
• Intervention / Treatment: Device: Biostrap arm band

• Study Type: Observational
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) receiving standard-of-care CAR-T cell therapy at Stanford University. Participants must be English-speaking and able, with caregiver assistance, to use wearable monitoring devices and perform blood microsampling. Up to 15 patients will be enrolled in this pilot study.

Description

Inclusion Criteria:

• Participant must be in the process of undergoing cancer cell therapy at Stanford University.

  • Adults > 18 years
  • Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.)
  • English speaking
  • Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection

Exclusion Criteria:

• In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CAR-T patients monitored with wearable devices and microsampling; All participants will receive wearable sensors, provide blood microsamples, and use the Biostrap mobile app for data capture. These are observational data collection tools applied to the entire cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring heart rate data	Defined as ≥70% of patients able to wear at least one sensor device for ≥50% of the days from CAR-T infusion (Day 0) to Day 28. Each day is counted if ≥12 hours of data are captured.	28 days
Monitoring temperature data	Proportion of patients able to wear at least one sensor device for ≥50% of days from Day 0 (CAR-T infusion) through Day 28, with ≥12 hours/day of usable data collected (temperature, heart rate).	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of wearable devices	Safety will be measured by skin irritation, rash. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices	28 days
Safety of the microsampling device	Microsampling will be measured by process such as minor bruising, bleeding, or infection. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices	28 days
Feasibility of microsampling	microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm	28 days

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Surbhi Sidana, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): July 7, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Leukemia; Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease
• Other Study ID Numbers: IRB-60459; NCI-2022-00603 (Registry Identifier: National Cancer Institute: Clinical Trials Reporting Program)

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