An observational study in Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome and B-Cell Lymphoma, sponsored by Current Health. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Current Health · Observational
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:
Participants will:
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.
137 studies on the registry are indexed under Cytokine Release Syndrome; 30 are open to participants now.
This study's planned enrollment of 125 is above the median of 103 across 28 observational studies indexed under Cytokine Release Syndrome.
Browse Cytokine Release Syndrome studies →Current Health is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of patients scheduled to receive liso-cel for a hematologic malignancy as an outpatient at participating institutions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Incidence of hospitalization
Number and percentage of participants hospitalized.
Time frame: Day 0 through Day +14
Time to hospital admission
Number of days between infusion and hospital admission, reported as median (IQR) and range.
Time frame: Day 0 through Day +14
Reason for hospitalization
Number and percent of participants for each hospitalization reason.
Time frame: Day 0 through Day +14
Hospital length of stay
Number of days in hospital (midnight to midnight), reported as median (IQR) and range.
Time frame: Day 0 through Day +14
Incidence of ICU admission
Number and percentage of participants admitted to an intensive care unit
Time frame: Day 0 through Day +14
Time to ICU admission
Number of days between infusion and ICU admission, reported as median (IQR) and range.
Time frame: Day 0 through Day +14
Reason for ICU admission
Number and percent of participants for each icu admission reason.
Time frame: Day 0 through Day +14
ICU length of stay
Number of days in ICU (midnight to midnight), reported as median (IQR) and range.
Time frame: Day 0 through Day +14
Incidence of emergency department visits
Number and percentage of participants with at least one emergency department visit
Time frame: Day 0 through Day +14
Time to first emergency department visit
Number of days between infusion and first visit, reported as median (IQR) and range.
Time frame: Day 0 through Day +14
Reason for emergency department visit
Number and percent of emergency department visits for each reason.
Time frame: Day 0 through Day +14
Mortality
Number and percentage of participants who died.
Time frame: Day 0 through Day 14
Incidence of Cytokine Release Syndrome (CRS)
Number and percentage of participants with CRS
Time frame: Day 0 through Day +14
Grade of Cytokine Release Syndrome (CRS)
Distribution of maximum CRS grade (Grade 0-4) per ASTCT consensus criteria (Lee 2019).
Time frame: Day 0 through Day +14
Time to onset of Cytokine Release Syndrome (CRS)
Days from infusion to CRS onset, reported as median (IQR) and range.
Time frame: Day 0 through Day +14
Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Number and percentage of participants with ICANS
Time frame: Day 0 through Day +14
Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Distribution of maximum ICANS grade (Grade 0-4) per ASTCT criteria (Lee 2019).
Time frame: Day 0 through Day +14
Time to onset of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Days from infusion to ICANS onset, reported as median (IQR) and range.
Time frame: Day 0 through Day +14
Prophylaxis for CAR T-Related Toxicities
Number and percentage of participants receiving prophylaxis (corticosteroids, anakinra, tocilizumab, other) for CAR T-related side effects, overall and by type.
Time frame: Day -3 through Day +14
Treatment of CAR T-Related Toxicities
Number and percentage of participants receiving treatment for CAR T-related side effects (antipyretics, corticosteroids, anakinra, tocilizumab, transfusion, antibiotics, antiemetics, other), overall and by type.
Time frame: Day 0 through Day +14
Time to treatment of CAR T-Related Toxicities
Time from infusion to administration of treatment for CAR T-related side effects (antipyretics, corticosteroids, anakinra, tocilizumab, transfusion, antibiotics, antiemetics, other), overall and by type.
Time frame: Day 0 through Day +14
Association Between RPM Data and Clinical Outcomes
Association of remote-patient monitoring derived vital sign trajectories and operational measures with primary outcomes (CRS, ICANS, hospitalization, ICU admission, and emergency department visits).
Time frame: Day 0 through Day 14
Association Between Baseline Characteristics and Clinical Outcomes
Associations of baseline characteristics (e.g., age, disease subtype, pre-lymphodepletion LDH, enrollment site, comorbidity burden) with remote patient monitoring data patterns and clinical outcomes.
Time frame: Day -3 through Day 14
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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