Wearable Sensors for Blood Cancers

Overseen By Sharan Claire

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How does the wearable sensor treatment for blood cancers differ from other treatments?

This treatment is unique because it uses a flexible wearable device combined with injectable nanoparticles to capture and kill circulating tumor cells in the blood, which can help prevent cancer from spreading. Unlike traditional treatments, this approach directly targets cancer cells in the bloodstream using a non-invasive method. ^{1 2 3 4 5}

Research Team

Surbhi Sidana, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 with Multiple Myeloma, Lymphoma, or Leukemia who are undergoing CAR-T cell therapy at Stanford University. Participants must speak English and be able to use wearable devices and collect blood samples with the help of a caregiver.

Inclusion Criteria

My treatment can target any cancer cell type.

I am over 18 years old.

You are receiving cancer treatment at Stanford University.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Chemotherapy

Participants undergo conditioning chemotherapy prior to CAR-T cell therapy

1 week

Daily visits (in-person) while in hospital

CAR-T Cell Therapy

Participants receive CAR-T cell therapy and are monitored for physiological and molecular changes

4 weeks

Daily monitoring (in-person) while in hospital, wearable sensor data collection

Follow-up

Participants are monitored for safety and effectiveness after CAR-T cell therapy, including adverse events management

4 weeks

Outpatient visits and wearable sensor data collection

Treatment Details

Interventions

• Biostrap arm band

Trial Overview The study tests if a Biostrap arm band can accurately monitor changes in patients' bodies during CAR-T therapy to manage side effects better. It also involves analyzing biological data (multiomic profile) alongside sensor and clinical data.

Participant Groups

Group I: Device physiological monitoring Experimental Treatment 1 Intervention

Patients will receive wearable sensor devices (Biostrap arm band)

Group II: Microsampling Active Control 1 Intervention

Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments.

Group III: Biostrap mobile App Active Control 1 Intervention

Data collection from wearable sensor.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

A new battery-free, wireless implantable device made entirely of bioresorbable materials can monitor internal body temperatures without the need for surgical extraction, reducing infection risks associated with traditional implants.

In tests on rat models, these devices operated stably for up to 4 days, showing promise for applications in monitoring healing processes and managing thermal therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioresorbable, Wireless, Passive Sensors as Temporary Implants for Monitoring Regional Body Temperature. Lu, D., Yan, Y., Avila, R., et al.[2021]

Biosensors have advanced significantly since their inception in 1962, and they are now being used in clinical settings, particularly for diagnosing and treating hematological cancers like acute myeloid leukemia and chronic myeloid leukemia.

Recent developments include biosensors that assess the effectiveness of cancer treatments, such as cytarabine and imatinib, which could lead to more personalized and effective treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosensors in clinical practice: focus on oncohematology. Fracchiolla, NS., Artuso, S., Cortelezzi, A.[2021]

A novel approach using flexible wearable electronics and injectable nanoparticles can effectively capture and eliminate circulating tumor cells (CTCs) from the bloodstream, potentially disrupting metastasis.

The system demonstrated a high capture efficiency of 72.31% for CTCs in a simulated blood circulation model, and the nanoparticles can induce CTC death within 10 minutes by rapidly increasing temperature when activated by light from embedded LEDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A flexible wearable device coupled with injectable Fe3O4 nanoparticles for capturing circulating tumor cells and triggering their deaths. Li, Y., Liu, X., Zhang, Y., et al.[2023]

A new miniaturized sensor system has been developed that can be integrated into vascular stents to monitor in-stent restenosis (ISR), which is a common complication after stent placement.

This sensor can detect different cell types involved in ISR and differentiate between blood and blood clots, providing valuable real-time information in a more realistic physiological environment compared to previous laboratory methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Cardiovascular Stent Complications Using Self-Reporting Biosensors for Noninvasive Detection of Disease. Hoare, D., Tsiamis, A., Marland, JRK., et al.[2023]

The composite microneedle array electrode (CMAE) is a novel device that can simultaneously monitor body temperature and bio-signals, showing excellent mechanical properties by successfully piercing porcine skin 100 times without damage.

CMAE measurements of body temperature closely match those from clinical thermometers, and it offers a more convenient method for monitoring bio-signals compared to traditional electrodes, as it eliminates the need for skin preparation and gel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fabrication of Composite Microneedle Array Electrode for Temperature and Bio-Signal Monitoring. Sun, Y., Ren, L., Jiang, L., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Bioresorbable, Wireless, Passive Sensors as Temporary Implants for Monitoring Regional Body Temperature. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Biosensors in clinical practice: focus on oncohematology. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A flexible wearable device coupled with injectable Fe3O4 nanoparticles for capturing circulating tumor cells and triggering their deaths. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Predicting Cardiovascular Stent Complications Using Self-Reporting Biosensors for Noninvasive Detection of Disease. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Fabrication of Composite Microneedle Array Electrode for Temperature and Bio-Signal Monitoring. [2018]