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Clinical Trial NCT07499128 for Cytokine Release Syndrome, Neoplasms, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Multiple Myeloma, Lymphoma Mantle-cell, Immunotherapy, Cell and Tissue-Based Therapy, Cytokines, Monitoring Physiologic, Immune Monitoring, Wearable Electronic Devices, Thermometry, Body Temperature, Antibodies Bispecific, Receptors Chimeric Antigen is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event 136

Not yet recruiting
Clinical Trial NCT07499128 is an interventional study for Cytokine Release Syndrome, Neoplasms, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Multiple Myeloma, Lymphoma Mantle-cell, Immunotherapy, Cell and Tissue-Based Therapy, Cytokines, Monitoring Physiologic, Immune Monitoring, Wearable Electronic Devices, Thermometry, Body Temperature, Antibodies Bispecific, Receptors Chimeric Antigen and is currently not yet recruiting. Enrollment is planned to begin on 5 April 2026 and continue until the study accrues 136 participants. Led by National Cancer Institute (NCI), this study is expected to complete by 18 August 2029. The latest data from ClinicalTrials.gov was last updated on 31 March 2026.
Brief Summary
Background:

Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems. Researchers want to know if continuously monitoring a person s body temperature can help reduce the chance of g...

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Detailed Description

Background:

  • Cellular therapy and cellular engager-based immunotherapy treatments, including but not limited to Chimeric Antigen Receptor (CAR) T-cell and bispecific T-cell engagers (BiTE), have an adverse event profile that often involves Grade >= 3 Cytokine Release Syndrome (CRS).
  • As a sequela of activating the immune system to engage their underlying cancer, CRS symptoms can range from grade 1 (e.g., fever am...
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Official Title

Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event

Conditions
Cytokine Release SyndromeNeoplasmsLymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaMultiple MyelomaLymphoma Mantle-cellImmunotherapyCell and Tissue-Based TherapyCytokinesMonitoring PhysiologicImmune MonitoringWearable Electronic DevicesThermometryBody TemperatureAntibodies BispecificReceptors Chimeric Antigen
Other Study IDs
  • 10002457
  • 002457-C
NCT ID Number
NCT07499128
Start Date (Actual)
2026-04-05
Last Update Posted
2026-03-31
Completion Date (Estimated)
2029-08-18
Enrollment (Estimated)
136
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Cytokine Release Syndrome
Continuous Temperature Monitoring
Wearable Device
TempTraq
Digital Oncology
VitalTraq
CRS Management
Fever Detection
Immunotherapy Toxicity
Bispecific T-cell Engager
Primary Purpose
Device Feasibility
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionControl Arm 2
Use of non-readable CTM devices, TempTraq without actionable alerts, and optional use of black-boxed VitalTraq
N/A
ExperimentalIntervention Arm 1
Use of non-readable CTM devices, TempTraq with actionable alerts, and optional use of black-boxed VitalTraq
TempTraq
Continuous temperature monitoring (CTM) wearable patch device
VitalTraq
Multi-vital, multi-sensor smartphone/ tablet application allowing data collection of blood pressure, heart rate, heart rate variability, and respiration rate using Remote Photoplethysmography technology (rPPG)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
To assess whether continuous observations of fevers with TempTraq versus intermittent fevers monitoring reduce the risk of progression to grade >= 3 cytokine release syndrome (CRS)
Posterior means of the CRS severe adverse event per arm will be reported, along with the corresponding 95% credible intervals in the highest density interval (HDI) based on the corresponding posterior distributions
TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduce the duration of CRS episodes
Posterior probability of at least 3% absolute risk reduction may be evaluated by two different stratification factors considered at randomization, separately, if applicable, with sufficient numbers of evaluable participants within the corresponding sub-populations
TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment
To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduces the escalation of CRS care
Posterior probability of at least 3% absolute risk reduction may be evaluated by two different stratification factors considered at randomization, separately, if applicable, with sufficient numbers of evaluable participants within the corresponding sub-populations
TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Age >= 18 years.
  • Participants must be enrolled in an active treatment protocol at NIH utilizing cellular therapy, cellular engagers, or other novel monotherapy or combination immunotherapy agents associated with a known or anticipated risk profile for grade >= 3 cytokine release syndrome (CRS) adverse effects.
  • Participants must be receiving immunotherapy dose(s) and be admitted to the Clinical Center. Note: Enrollment during the first week of treatment on an active treatment protocol, when CRS risk is highest, is preferable, but starting later during their active treatment course is acceptable.
  • Ability of the participant to understand and the willingness to sign a written informed consent document.

  • Prior solid organ or stem cell transplantation on active immunosuppression.
  • Regimen including antibiotics, for documented active infection within 7 days prior to study enrollment.
  • Current syndrome associated with cyclic fevers.
  • History of severe drug allergies, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
  • Known current alcohol use disorder or drug use disorder that, in the opinion of the investigator, would interfere with the participant s ability to comply with study procedures or safely participate in the study.
National Cancer Institute (NCI) logoNational Cancer Institute (NCI)
Study Central Contact
Contact: Karen C Kwok, C.R.N.P., (240) 620-0858, [email protected]
Contact: Nicholas P Tschernia, M.D., (240) 506-3532, [email protected]
1 Study Locations in 1 Countries

Maryland

National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States
National Cancer Institute Referral Office, Contact, 888-624-1937, [email protected]