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

Not Applicable

Recruiting

• Conditions: Hodgkin Lymphoma; Multiple Myeloma; Non Hodgkin Lymphoma; Leukemia
• Interventions: Device: Biostrap arm band

• Registration Number: NCT05123001
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-15
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-07
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device physiological monitoring	Biostrap arm band	Patients will receive wearable sensor devices (Biostrap arm band)

Primary Outcome Measures

Name	Time	Method
Monitoring heart rate data	28 days
Monitoring temperature data	28 days

Secondary Outcome Measures

Name	Time	Method
Safety of wearable devices	28 days	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
Safety of the microsampling device	28 days	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
Microsampling	28 days	microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States