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

September 29, 2026 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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 Backup

Study Locations

  • France
      • Saint-Etienne, 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
Experimental: CAR T cell treatment

Major patients for whom CAR-T treatment is indicated.
Biological: Biological tests

Biological tests : cell quantification et characterization

Diagnostic test: MRI

MRI

Diagnostic test: Neuropsychological tests

Neuropsychological tests

What is the study measuring?

Primary Outcome Measures

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

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

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Emilie CHALAYER, MD, Centre Hospitalier Universitaire de 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)

July 2, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 30, 2026

Last Update Submitted That Met QC Criteria

September 29, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID 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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