Clinical Research Directory

RPM Signals in Outpatient CAR T Therapy

Sponsor: Current Health

Summary

The goal of this observational study is to learn how patients' vital signs and symptoms change during outpatient CAR T-cell therapy with lisocabtagene maraleucel (liso-cel), a type of cancer treatment. The study tracks vital signs and other health data at home using wearable monitoring devices. It includes adults with blood cancers who are receiving liso-cel as outpatients, meaning they are at home rather than staying in the hospital during treatment. The main questions it aims to answer are: * What do patients' vital signs and monitoring data look like from 3 days before through 14 days after their CAR T-cell infusion, and what side effects do they experience, such as cytokine release syndrome (a fever and inflammation reaction) and neurological side effects? * How are patients' individual characteristics and monitoring data related to these side effects? Participants will: * Use the Current Health home monitoring kit, including a wearable device that tracks breathing rate, pulse, oxygen levels, skin temperature, and step count, plus a blood pressure cuff, a temperature patch, a thermometer, a tablet, and a device that sends data without needing home internet. Monitoring starts 3 days before infusion and continues for 14 days afterward, pausing during any hospital stays. * Answer short questions about their experience on the tablet. * Continue their regular medical care and appointments. The study team will collect information from their medical records, such as test results, treatment details, and any side effects or complications. Participants receive CAR T-cell therapy as part of their regular care. The study does not test or change any treatment. Researchers are only observing and recording what happens during this at-home care model.

Official title: Characterizing Remote Patient Monitoring Signals During Outpatient CAR T Therapy: A Prospective Observational Cohort Study

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