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

Study Overview
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Brief Summary
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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): To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients. To generate comprehensive multiomic profile analysis following CAR-T therapy. To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.

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

Conditions
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Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia, Multiple Myeloma

Intervention / Treatment
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* Device: Biostrap arm band


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device physiological monitoring<br>Patients will receive wearable sensor devices (Biostrap arm band) | Device: Biostrap arm band<br>* The Biostrap mobile app will connect with the Biostrap arm band and temperature sensor.<br>|
| No Intervention: Microsampling<br>Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments. | |
| No Intervention: Biostrap mobile App<br>Data collection from wearable sensor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring heart rate data |  | 28 days | 
| Monitoring temperature data |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microsampling | microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm | 28 days | 
| 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 |