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

Stanford University

Status: Completed

Conditions: Hodgkin Lymphoma; Multiple Myeloma; Leukemia; Non Hodgkin Lymphoma

Treatments: Device: Biostrap arm band

Study type: Observational

Funder types: Other

Identifiers

NCT05123001

IRB-60459

NCI-2022-00603 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

11 participants in 1 patient group

CAR-T patients monitored with wearable devices and microsampling

Description:

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.