Detection of cytokine release syndrome using wearables and cytokine profiling following CAR-T therapy for myeloma

Sridevi Rajeeve; Matt Wilkes; Nicole Zahradka; Lewis Tomalin; Mujahid Quidwai; Darren Pan; Nicholas J. Calafat; Martin Cusack; Adolfo Aleman; Kseniya Serebryakova; Katerina Kappes; Hayley Jackson; Sarita Agte; Santiago Thibaud; Larysa Sanchez; Shambavi Richard; Joshua Richter; Cesar Rodriguez; Hearn Jay Cho; Ajai Chari; Sundar Jagannath; Alessandro Laganà; Adriana C. Rossi; Samir Parekh

doi:10.1172/jci.insight.203988

Detection of cytokine release syndrome using wearables and cytokine profiling following CAR-T therapy for myeloma

Sridevi Rajeeve,¹ Matt Wilkes,² Nicole Zahradka,² Lewis Tomalin,³ Mujahid Quidwai,⁴ Darren Pan,⁵ Nicholas J. Calafat,² Martin Cusack,² Adolfo Aleman,⁶ Kseniya Serebryakova,⁶ Katerina Kappes,⁶ Hayley Jackson,⁶ Sarita Agte,⁷ Santiago Thibaud,⁶ Larysa Sanchez,⁶ Shambavi Richard,⁶ Joshua Richter,⁶ Cesar Rodriguez,⁶ Hearn Jay Cho,⁶ Ajai Chari,⁵ Sundar Jagannath,⁶ Alessandro Laganà,⁴ Adriana C. Rossi,⁶ and Samir Parekh⁶

Published May 5, 2026 - More info

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Abstract

BACKGROUND. Chimeric antigen receptor T-cell (CAR-T) therapies have revolutionized treatment for relapsed/refractory multiple myeloma (RRMM). However, cytokine release syndrome (CRS), a common and potentially severe complication, requires inpatient monitoring, limiting access and increasing costs. Wearable devices could support outpatient CAR-T delivery, but feasibility for CRS detection versus standard care remains unproven.

METHOD. We conducted a prospective, single-center observational pilot study to assess the feasibility of using wearable devices for monitoring vital signs and detecting CRS. Thirty patients receiving idecabtagene vicleucel (ide-cel) or ciltacabtagene autoleucel (cilta-cel) were enrolled; 25 with sufficient monitoring data were evaluable. Sensors collected skin and axillary temperature, oxygen saturation, respiratory and heart rate, and motion. Peripheral blood cytokines were analyzed pre- and post-infusion using a multiplex proteomic platform. The primary outcome was feasibility, assessed by CRS detection sensitivity and specificity; secondary outcomes included adherence, lead time, and performance of models integrating wearable and cytokine data.

RESULTS. CRS occurred in 20 of 25 patients. The best-performing wearable model detected 18 or 20 CRS episodes with a sensitivity of 0.72 (mean 0.75; 95% CI 0.60–0.91) and a specificity of 0.80 (mean 0.76; 95% CI 0.68–0.84), and a median lead time of 7:00 hours before nursing recognition. Median adherence during high-risk periods was 71%. Cytokine changes paralleled temperature elevations, and IFN-γ emerged as a consistent biomarker.

CONCLUSION. Wearable devices are feasible for early CRS detection and may support outpatient CAR-T care. Larger outpatient studies are warranted.

TRIAL REGISTRATION. This study did not meet the criteria for ClinicalTrials.gov registration.

Detection of cytokine release syndrome using wearables and cytokine profiling following CAR-T therapy for myeloma

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