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

Status: Completed
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
California
Stanford University
Palo Alto
Time Frame
Start Date: 2021-07-15
Completion Date: 2022-07-07
Participants
Target number of participants: 11
Treatments
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.
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov

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