Immune Effector Cell Associated Neurotoxicity SyndromePhase 4VESICANSNCT06706102
Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
A Phase 4 study testing Biological tests, MRI and Neuropsychological tests in people with Immune Effector Cell Associated Neurotoxicity Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Effector Cell Associated Neurotoxicity Syndrome
- What is being tested?
- Biological tests, MRI and Neuropsychological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2025to Nov 2027
- Phase
- Phase 4
- 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
Who may be able to join
- Patient aged over 18,
- Patient for whom CAR-T treatment is indicated,
- Patient affiliated to a social security system
- Patient who give his consent to participate in the study.
Who cannot join
- Pregnant or breastfeeding woman,
- Patient unable to understand informed consent,
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Emilie CHALAYER, MD, (0)4 77 82 28 14 ext. 33, emilie.chalayer@chu-st-etienne.fr
Jérôme CORNILLON, MD
About this study
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.
- Being tested
- Biological tests, MRI, Neuropsychological tests
- Keywords
- CAR-T Cell, ICANS, EVs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological testsBiological
Biological tests : cell quantification et characterization
MRIDiagnostic test
MRI
Neuropsychological testsDiagnostic test
Neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| CAR T cell treatment | Experimental | Major patients for whom CAR-T treatment is indicated. Receives: Biological: Biological tests; Diagnostic Test: MRI; Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Cerabral involvement on RMI
Diffusion tensor imaging and resting state default mode network
Measured: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start2 Jul 2025
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Effector Cell Associated Neurotoxicity 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie CHALAYER, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706102
- Sponsor's protocol ID
- 24CH009
- Other IDs
- 2024-515328-35-00
- Acronym
- VESICANS
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2024
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
- ClinicalTrials.gov ID
- NCT06706102
- Acronym / sponsor ID
- VESICANS / 24CH009
- Keywords
- CAR-T Cell, ICANS, EVs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 26 Nov 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR T cell treatment | Experimental | Biological: Biological tests, Diagnostic Test: MRI, Diagnostic Test: Neuropsychological testsMajor patients for whom CAR-T treatment is indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged over 18,
- Patient for whom CAR-T treatment is indicated,
- Patient affiliated to a social security system
- Patient who give his consent to participate in the study.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman,
- Patient unable to understand informed consent,
- Patient under legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological testsBiological tests : cell quantification et characterization | Biological | CAR T cell treatment |
| MRIMRI | Diagnostic test | CAR T cell treatment |
| Neuropsychological testsNeuropsychological tests | Diagnostic test | CAR T cell treatment |
Primary outcome
Endothelial EVs quantification (EVs/mL)
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
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.
Endothelial EVs characterization (immunophenotyping)
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
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.
11 secondary outcomes
Other EV subtypes quantification (EV subtype/mL)
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Other EV subtypes characterization (immunophenotyping)
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)
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)
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVs quantification according to levels of cytokines (EVs/mL)
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
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)
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
EVs characterization in cerebrosinalfluid.
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.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Association of EVs subpopulations in neuropsychological test and RMI.
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Cerabral involvement on RMI
Time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
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 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Immune Effector Cell Associated Neurotoxicity Syndrome
Not yet recruitingObservational study
RPM Signals in Outpatient CAR T Therapy
Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome
Recruiting
Assessing DCog Short for Neurotoxicity in CAR-T
Neurotoxicity, Neurotoxicity Syndromes
RecruitingPhase 2
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma
Refractory Multiple Myeloma
Not yet recruitingPhase 2
Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS
Multiple Myeloma, Large B-cell Lymphoma (LBCL)
RecruitingPhase 2
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
Multiple Myeloma
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.
Emilie CHALAYER, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biological tests, MRI and Neuropsychological tests in people with Immune Effector Cell Associated Neurotoxicity Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Emilie CHALAYER, MD ((0)4 77 82 28 14 ext. +33, emilie.chalayer@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial EVs quantification (EVs/mL) (time frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60). The study lists 2 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 30 Sep 2026.