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

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05123001
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma; Non Hodgkin Lymphoma; Leukemia; Multiple Myeloma	Device: Biostrap arm band	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
• Actual Study Start Date: Jul 15, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device physiological monitoring Patients will receive wearable sensor devices (Biostrap arm band)	Device: Biostrap arm band; The Biostrap mobile app will connect with the Biostrap arm band and temperature sensor.
No Intervention: Microsampling 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 Data collection from wearable sensor.

Outcome Measures

Primary Outcome Measures

1. Monitoring heart rate data [28 days]

2. Monitoring temperature data [28 days]

Secondary Outcome Measures

1. Microsampling [28 days]

   microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Surbhi Sidana, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT05123001
• Other Study ID Numbers: IRB-60459; CCT5049; NCI-2022-00603
• First Posted: Nov 17, 2021
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Multiple Myeloma

Study Results

No Results Posted as of Apr 7, 2022