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NCT Number: NCT06706102

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

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.

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Key information

Conditions

Immune Effector Cell Associated Neurotoxicity Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Emilie CHALAYER, MD

CONTACT

[email protected]

(0)4 77 82 28 14 ext. 33

Emmanuelle TAVERNIER, MD

SUB_INVESTIGATOR

Jérôme CORNILLON, MD

SUB_INVESTIGATOR

Ludovic FOUILLET, MD

SUB_INVESTIGATOR

Manon SAPET, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological tests

Biological

Biological tests : cell quantification et characterization

MRI

Diagnostic Test

MRI

Neuropsychological tests

Diagnostic Test

Neuropsychological tests

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie CHALAYER, MD

CONTACT

[email protected]

(0)4 77 82 28 14 ext. +33

Hélène RAINGARD

CONTACT

[email protected]

(0)4 77 82 97 03 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: VESICANS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2024
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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