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NCT07882732

RPM Signals in Outpatient CAR T Therapy

StatusNot Yet Recruiting

PhaseNot specified

SponsorCurrent Health

Primary completionDec 1, 2027 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 12, 2026 Study First Submitted

Endpoints

Primary

Incidence of hospitalization

Timeframe: Day 0 through Day +14

Time to hospital admission

Timeframe: Day 0 through Day +14

Reason for hospitalization

Timeframe: Day 0 through Day +14

Hospital length of stay

Timeframe: Day 0 through Day +14

Incidence of ICU admission

Timeframe: Day 0 through Day +14

Time to ICU admission

Timeframe: Day 0 through Day +14

Reason for ICU admission

Timeframe: Day 0 through Day +14

ICU length of stay

Timeframe: Day 0 through Day +14

Incidence of emergency department visits

Timeframe: Day 0 through Day +14

Time to first emergency department visit

Timeframe: Day 0 through Day +14

Reason for emergency department visit

Timeframe: Day 0 through Day +14

Mortality

Timeframe: Day 0 through Day 14

Incidence of Cytokine Release Syndrome (CRS)

Timeframe: Day 0 through Day +14

Grade of Cytokine Release Syndrome (CRS)

Timeframe: Day 0 through Day +14

Time to onset of Cytokine Release Syndrome (CRS)

Timeframe: Day 0 through Day +14

Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Timeframe: Day 0 through Day +14

Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Timeframe: Day 0 through Day +14

Time to onset of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Timeframe: Day 0 through Day +14

Prophylaxis for CAR T-Related Toxicities

Timeframe: Day -3 through Day +14

Treatment of CAR T-Related Toxicities

Timeframe: Day 0 through Day +14

Time to treatment of CAR T-Related Toxicities

Timeframe: Day 0 through Day +14

Secondary (2)

Association Between RPM Data and Clinical Outcomes

Association Between Baseline Characteristics and Clinical Outcomes

About this trial

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.

Trial details

Enrollment: 125 participants (estimated)
Started: Dec 1, 2026
Study completion: Dec 1, 2027 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Cytokine Release Syndrome, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Immune Effector Cell-Associated Neurotoxicity Syndrome, Chronic Lymphocytic Leukemia
Official title: Characterizing Remote Patient Monitoring Signals During Outpatient CAR T Therapy: A Prospective Observational Cohort Study
First posted: Oct 20, 2026
Registry updated: Oct 20, 2026
Last verified: Oct 2026

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