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Recruiting NCT06706102

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

Phase IV Interventional Immune Effector Cell Associated Neurotoxicity Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological tests, MRI, Neuropsychological tests.
Who it may be relevant to
Registry conditions: Immune Effector Cell Associated Neurotoxicity Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Biological Biological tests
    Biological tests : cell quantification et characterization
  • Diagnostic test MRI
    MRI
  • Diagnostic test Neuropsychological tests
    Neuropsychological tests

Primary outcome measures

  • Endothelial EVs quantification (EVs/mL) [Time frame: 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]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT06706102 · 24CH009 · 2024-515328-35-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗