Using wearable sensors to monitor and manage side effects of CAR-T therapy
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
This study is testing if wearable sensors can help track side effects in patients receiving CAR-T therapy for blood cancers to improve their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | CAR-T, Chimeric antigen receptor |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05123001 on ClinicalTrials.gov |
What this trial studies
This study focuses on monitoring physiological and molecular changes in patients undergoing CAR-T cell therapy for various blood cancers. It aims to assess the feasibility and effectiveness of wearable sensors in detecting adverse events such as Cytokine Release Syndrome and neurotoxicity. The study will also generate comprehensive multiomic profiles and integrate data from wearable sensors, omics, and clinical symptoms to improve patient management during therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years who are undergoing CAR-T therapy at Stanford University and can use wearable devices.
Not a fit: Patients who are not undergoing CAR-T therapy or those unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better early detection and management of adverse events in patients receiving CAR-T therapy.
How similar studies have performed: While the integration of wearable technology and molecular profiling is a novel approach, similar studies have shown promise in monitoring patient outcomes in other therapeutic areas.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Surbhi Sidana — Stanford University
- Study coordinator: Sharan Claire
- Email: sharanclaire@stanford.edu
- Phone: 650-721-4091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.