A Phase 4 interventional study of Biological tests and MRI in Immune Effector Cell Associated Neurotoxicity Syndrome, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 4, Interventional, and Basic science
Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) is a common and serious neurological complication associated with the use of CAR-T cells. The mechanisms involved are still poorly understood but studies suggest that inflammation during treatment leads to an increase in the permeability of the barrier between the brain and the blood vessels and the emission of extracellular vesicles (EVs) circulating between the brain and the blood vessels. EVs are biological particles that play an important role in cellular communication and the modulation of several physiological processes. The VESICANS study aims to characterize the EVs released before and during CAR-T cells treatment and upon the occurrence of ICANS, using flow cytometry, electron microscopy, Nanoparticle Tracking Analysis associated with MRI assessment of the barrier between the brain and blood. This study will ultimately contribute to facilitating the prevention and treatment of this toxicity which affects the prognosis of patients.
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Major patients for whom CAR-T treatment is indicated.
Biological: Biological tests · Diagnostic Test: MRI · Diagnostic Test: Neuropsychological tests
Biological tests : cell quantification et characterization
MRI
Neuropsychological tests
Endothelial EVs quantification (EVs/mL)
Quantification by Nano Tracking Analysis of endothelial EVs as a function of time before and after treatment with CAR-T cells according to ICANS grade.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Endothelial EVs characterization (immunophenotyping)
Characterization by Nano Tracking Analysis (immunophenotyping by size) of endothelial EVs as a function of time before and after treatment with CAR-T cells according to ICANS grade.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Other EV subtypes quantification (EV subtype/mL)
Other EV subtypes quantification of as a function of time before and after treatment with CAR-T cells according to ICANS grade.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Other EV subtypes characterization (immunophenotyping)
Other EV subtypes characterization of as a function of time before and after treatment with CAR-T cells according to ICANS grade.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVS quantification according to the presence of an ICANS versus no ICANS (EV/mL)
EVS quantification according to the presence of an ICANS versus no ICANS
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVs characterization according to the presence of an ICANS versus no ICANS (immunophenotyping)
EVS characterization of EVs according to the presence of an ICANS versus no ICANS
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVs quantification according to levels of cytokines (EVs/mL)
EVs quantification according to levels of cytokines
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVs characterization according to levels of cytokines
EVs characterization according to levels of cytokines
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVs quantification in cerebrospinal fluid (EVs/mL)
EVs quantification after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVs characterization in cerebrosinalfluid.
EVs characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Association of EVs subpopulations in clinical neurological damage and sleep apnea syndrome.
Characterization of the association of subpopulations of EVs according to clinical neurological damage and sleep apnea syndrome.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Association of EVs subpopulations in neuropsychological test and RMI.
Characterization of the association of subpopulations of EVs according to neuropsychological test and RMI.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Cerabral involvement on RMI
Diffusion tensor imaging and resting state default mode network
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
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 ↗
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Centre Hospitalier Universitaire de Saint Etienne