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

Stanford University11 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hodgkin Lymphoma Non Hodgkin Lymphoma Leukemia Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Monitoring heart rate data

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.

Time frame: 28 days

Monitoring temperature data

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).

Time frame: 28 days

Secondary Outcomes

Feasibility of microsampling

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

Time frame: 28 days

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

Time frame: 28 days

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

Time frame: 28 days

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes