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

NCT05123001 | Completed DMC

• 2 other identifiers: IRB-60459NCI-2022-00603
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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. 1.To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
2. 2.To generate comprehensive multiomic profile analysis following CAR-T therapy.
3. 3.To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.

Conditions

Hodgkin Lymphoma; Non Hodgkin Lymphoma; Leukemia; Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  28 days

Secondary Outcomes (3)

• Feasibility of microsampling

  28 days

• Safety of wearable devices

  28 days

• Safety of the microsampling device

  28 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) receiving standard-of-care CAR-T cell therapy at Stanford University. Participants must be English-speaking and able, with caregiver assistance, to use wearable monitoring devices and perform blood microsampling. Up to 15 patients will be enrolled in this pilot study.

You may qualify if:

• 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

You may not qualify if:

• In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Leukemia; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Surbhi Sidana

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 17, 2021
• Study Start: July 15, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)