Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome (VESICANS)

July 4, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • Recruiting
        • CHU de Saint-Etienne
        • Sub-Investigator:
          • Ludovic FOUILLET, MD
        • Sub-Investigator:
          • Emmanuelle TAVERNIER, MD
        • Contact:
        • Sub-Investigator:
          • Jérôme CORNILLON, MD
        • Sub-Investigator:
          • Manon SAPET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Pregnant or breastfeeding woman,
  • Patient unable to understand informed consent,
  • Patient under legal protection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAR T cell treatment
Major patients for whom CAR-T treatment is indicated.
Diagnostic test: MRI
MRI
Biological: Biological tests
Biological tests : cell quantification et characterization
Diagnostic test: Neuropsychological tests
Neuropsychological tests

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
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.
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other EV subtypes quantification (EV subtype/mL)
Time Frame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Other EV subtypes quantification of as a function of time before and after treatment with CAR-T cells according to ICANS grade.
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
Other EV subtypes characterization of as a function of time before and after treatment with CAR-T cells according to ICANS grade.
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 quantification according to the presence of an ICANS versus no ICANS
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 characterization of EVs according to the presence of an ICANS versus no ICANS
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 quantification according to levels of cytokines
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 characterization according to levels of cytokines
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 quantification after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.
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
EVs characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.
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
Characterization of the association of subpopulations of EVs according to clinical neurological damage and sleep apnea syndrome.
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
Characterization of the association of subpopulations of EVs according to neuropsychological test and RMI.
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
Diffusion tensor imaging and resting state default mode network
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emilie CHALAYER, MD, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24CH009
  • 2024-515328-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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