Cytokine Release SyndromeNCT07882732
RPM Signals in Outpatient CAR T Therapy
An observational study of Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome, run by Current Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, B-Cell Lymphoma
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients scheduled to receive liso-cel for a hematologic malignancy as an outpatient at participating institutions.
Who may be able to join
- Patients scheduled to receive liso-cel as an outpatient for a hematologic malignancy at a participating institution
- Meet the participating institution's outpatient CAR T program's eligibility criteria
- Able to use and return the monitoring device
- English- or Spanish-speaking and willing to use the interpreter services available via the platform if needed
Who cannot join
- Inability or unwillingness to provide informed consent
- Age under 18 years
- Inpatient admission planned at time of enrollment
- Any contraindication to use the Current Health wearable device as listed by the device manufacturer in the device Instructions For Use.
- Participation in another interventional study that would confound study outcomes, unless approved by both studies' principal investigators.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Characterizing Remote Patient Monitoring Signals During Outpatient CAR T Therapy: A Prospective Observational Cohort Study
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:
Read more
- 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.
- Conditions
- Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, B-Cell Lymphoma, Chronic Lymphocytic Leukemia
- Keywords
- wearable device, CAR T-cell therapy, outpatient, remote patient monitoring
- Medical subject headings
- Cytokine Release Syndrome, Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospitalization
Number and percentage of participants hospitalized.
Measured: Day 0 through Day +14
Time to hospital admission
Number of days between infusion and hospital admission, reported as median (IQR) and range.
Measured: Day 0 through Day +14
Reason for hospitalization
Number and percent of participants for each hospitalization reason.
Measured: Day 0 through Day +14
Hospital length of stay
Number of days in hospital (midnight to midnight), reported as median (IQR) and range.
Measured: Day 0 through Day +14
Incidence of ICU admission
Number and percentage of participants admitted to an intensive care unit
Measured: Day 0 through Day +14
Time to ICU admission
Number of days between infusion and ICU admission, reported as median (IQR) and range.
Measured: Day 0 through Day +14
Reason for ICU admission
Number and percent of participants for each icu admission reason.
Measured: Day 0 through Day +14
ICU length of stay
Number of days in ICU (midnight to midnight), reported as median (IQR) and range.
Measured: Day 0 through Day +14
Incidence of emergency department visits
Number and percentage of participants with at least one emergency department visit
Measured: 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.
Measured: Day 0 through Day +14
Reason for emergency department visit
Number and percent of emergency department visits for each reason.
Measured: Day 0 through Day +14
Mortality
Number and percentage of participants who died.
Measured: Day 0 through Day 14
Incidence of Cytokine Release Syndrome (CRS)
Number and percentage of participants with CRS
Measured: 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).
Measured: 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.
Measured: Day 0 through Day +14
Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Number and percentage of participants with ICANS
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 through Day +14
Secondary outcomes (2)
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).
Measured: 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.
Measured: Day -3 through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine Release SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Current Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Zahradka, Study director, Current Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882732
- Sponsor's protocol ID
- PRO04134370
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Remote Patient Monitoring Signals During Outpatient CAR T Therapy: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07882732
- Acronym / sponsor ID
- PRO04134370
- Conditions
- Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, B-Cell Lymphoma, Chronic Lymphocytic Leukemia
- Keywords
- wearable device, CAR T-cell therapy, outpatient, remote patient monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Current HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients scheduled to receive liso-cel for a hematologic malignancy as an outpatient at participating institutions.
Key inclusion criteria (4 listed)
- Patients scheduled to receive liso-cel as an outpatient for a hematologic malignancy at a participating institution
- Meet the participating institution's outpatient CAR T program's eligibility criteria
- Able to use and return the monitoring device
- English- or Spanish-speaking and willing to use the interpreter services available via the platform if needed
Key exclusion criteria (5 listed)
- Inability or unwillingness to provide informed consent
- Age under 18 years
- Inpatient admission planned at time of enrollment
- Any contraindication to use the Current Health wearable device as listed by the device manufacturer in the device Instructions For Use.
- Participation in another interventional study that would confound study outcomes, unless approved by both studies' principal investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hospitalization
Time frame: Day 0 through Day +14
Number and percentage of participants hospitalized.
Time to hospital admission
Time frame: Day 0 through Day +14
Number of days between infusion and hospital admission, reported as median (IQR) and range.
Reason for hospitalization
Time frame: Day 0 through Day +14
Number and percent of participants for each hospitalization reason.
Hospital length of stay
Time frame: Day 0 through Day +14
Number of days in hospital (midnight to midnight), reported as median (IQR) and range.
Incidence of ICU admission
Time frame: Day 0 through Day +14
Number and percentage of participants admitted to an intensive care unit
Time to ICU admission
Time frame: Day 0 through Day +14
Number of days between infusion and ICU admission, reported as median (IQR) and range.
Reason for ICU admission
Time frame: Day 0 through Day +14
Number and percent of participants for each icu admission reason.
ICU length of stay
Time frame: Day 0 through Day +14
Number of days in ICU (midnight to midnight), reported as median (IQR) and range.
Incidence of emergency department visits
Time frame: Day 0 through Day +14
Number and percentage of participants with at least one emergency department visit
Time to first emergency department visit
Time frame: Day 0 through Day +14
Number of days between infusion and first visit, reported as median (IQR) and range.
Reason for emergency department visit
Time frame: Day 0 through Day +14
Number and percent of emergency department visits for each reason.
Mortality
Time frame: Day 0 through Day 14
Number and percentage of participants who died.
Incidence of Cytokine Release Syndrome (CRS)
Time frame: Day 0 through Day +14
Number and percentage of participants with CRS
Grade of Cytokine Release Syndrome (CRS)
Time frame: Day 0 through Day +14
Distribution of maximum CRS grade (Grade 0-4) per ASTCT consensus criteria (Lee 2019).
Time to onset of Cytokine Release Syndrome (CRS)
Time frame: Day 0 through Day +14
Days from infusion to CRS onset, reported as median (IQR) and range.
Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: Day 0 through Day +14
Number and percentage of participants with ICANS
Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: Day 0 through Day +14
Distribution of maximum ICANS grade (Grade 0-4) per ASTCT criteria (Lee 2019).
Time to onset of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: Day 0 through Day +14
Days from infusion to ICANS onset, reported as median (IQR) and range.
Prophylaxis for CAR T-Related Toxicities
Time frame: Day -3 through Day +14
Number and percentage of participants receiving prophylaxis (corticosteroids, anakinra, tocilizumab, other) for CAR T-related side effects, overall and by type.
Treatment of CAR T-Related Toxicities
Time frame: Day 0 through Day +14
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 to treatment of CAR T-Related Toxicities
Time frame: Day 0 through Day +14
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.
2 secondary outcomes
Association Between RPM Data and Clinical Outcomes
Time frame: Day 0 through Day 14
Association Between Baseline Characteristics and Clinical Outcomes
Time frame: Day -3 through Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Zahradka study director
Current Health Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome, run by Current Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director of Health Outcomes and Value (857-335-4614, nicole.zahradka@currenthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospitalization (time frame: Day 0 through Day +14). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.