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

Not Applicable

Completed

• Conditions: Hodgkin Lymphoma; Multiple Myeloma; Non Hodgkin Lymphoma; Leukemia

• 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

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
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-07
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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