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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05123001
• Other study ID #: IRB-60459
• Secondary ID: CCT5049NCI-2022-
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Sharan Claire
• Phone: 650-721-4091
• Email: sharanclaire[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Lymphoma
• Leukemia
• Lymphoma
• Multiple Myeloma
• Non Hodgkin Lymphoma

Intervention

Device:
• Biostrap arm band
The Biostrap mobile app will connect with the Biostrap arm band and temperature sensor.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring heart rate data		28 days
Primary	Monitoring temperature data		28 days
Secondary	Microsampling	microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm	28 days
Secondary	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
Secondary	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