Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphosarcoma

Hodgkin Lymphoma

Patients will receive wearable sensor devices (Biostrap arm band)

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

The Biostrap mobile app will connect with the Biostrap arm band and temperature sensor.

Biostrap arm band

Sharan Claire

Surbhi Sidana, MD

Michael P. Snyder, PhD

David Miklos, MD, PhD

Matthew Frank, MD, PhD

Theresa Latchford, MS

Ryan Kellogg, PhD

Surbhi Sidana

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.

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

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

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

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

Stanford University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events	NCT05123001	Hodgkin Lymphom... Non Hodgkin Lym... Leukemia Multiple Myelom...	Biostrap arm ba...	18 Years -	Stanford University
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events	NCT05123001	Hodgkin Lymphom... Non Hodgkin Lym... Leukemia Multiple Myelom...	Biostrap arm ba...	18 Years -	Stanford University

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