American Society of Hematology Annual Meeting

Wearable Device Detects CRS in CAR-T Therapy Earlier Than Standard-of-Care Nurse Monitoring

Avatar photoBryant Furlow
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Cancer patient
Cancer patient
Researchers investigated the feasibility of using a wearable device to monitor patients with RRMM for CRS after undergoing CAR-T therapy, compared with standard-of-care nurse-recorded monitoring.

Continuous remote monitoring of patient vital signs using a wearable device reliably detects cytokine release syndrome (CRS) earlier than standard-of-care (SOC) nurse-recorded vital signs in patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy for relapsed/refractory multiple myeloma (RRMM), according to findings from a pilot study presented at the ASH Annual Meeting 2023.

“Preliminary results suggest that time to cytokine release syndrome detection by the wearable device preceded SOC detection without any missed events … up to 184 minutes earlier,” reported Sridevi Rajeeve, MD, of Memorial Sloan Kettering Cancer Center in New York. “Objective and reliable CRS monitoring may help safely transition workflows to outpatient CAR-T administration models.”

Data from the wearable device were analyzed based on 2 thresholds: patient’s temperature breached a fixed threshold of 38°C, defined as fever by the American Society of Transplantation and Cellular Therapy (ASTCT); and patient’s temperature breached an individualized threshold of 2 standard deviations above their baseline temperature. 

The loop-strap monitoring device is worn on the patient’s upper arm. It continuously collects patient temperature, pulse, respiratory rate, and oxygen saturation. SOC nurse-recorded vital signs are also recorded from the day of CAR-T infusion to discharge. Blood was collected for later proteomics analysis, Dr Rajeeve said.

A total of 28 patients enrolled. They wore the device for 12 to 15 days (median, 13 days) and adherence was 64% overall and 72% during CRS high-risk periods. 

Most patients experienced CRS events (only 5 patients [17.8%] did not), although 17 of 21 (80%) CRS events were grade 1. No CRS events as determined by SOC were missed using the wearable device.

Three patients in the “no CRS” group had apparent false-positive CRS detection by the device, but these might really have been subclinical CRS events missed by SOC, Dr Rajeeve said.

“While the low false detection rate is very encouraging, these may also potentially be attributed to subclinical events,” she said. “[C]alibrating alarm systems of the variable devices to detect sustained changes in vital signs over isolated or physiological breaches are required to help reduce alarm fatigue and for accurate capture of early pathologic changes.”

The wearable device detected CRS a median of 22 minutes (range, 13 to 113.5 minutes) earlier than SOC using a fixed temperature threshold and a median of 184 minutes earlier than SOC using individualized temperature threshold.

Multi-institutional validation studies are needed to confirm the pilot study’s findings, Dr Rajeeve said. The study team next plans to study cytokine biomarkers for early CRS detection, alone and alongside wearable device data. Using machine learning models, they hope to build new CRS prediction and risk stratification tools.

Disclosures: This research was supported by the ASCO Conquer Cancer Foundation, Bristol Myers Squibb, Current Health, and Best Buy Health. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Rajeeve S, Zahradka N, Wilkes M, et al. Early and consistent CRS detection using wearable device for remote patient monitoring following CAR-T therapy in relapsed/refractory multiple myeloma (RRMM): early results of an investigator-initiated trial. Presented at ASH 2023. December 9-12, 2023. San Diego, CA. Abstract 1007.