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

NCT06706102 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Phase

Phase 4

Started

2025-07-02

Last updated

2026-09-30

Condition(s) studied

Immune Effector Cell Associated Neurotoxicity Syndrome

Investigational drug(s) / intervention(s)

Biological tests →MRINeuropsychological tests

Biological tests: Biological tests : cell quantification et characterization

MRI: MRI

Neuropsychological tests: Neuropsychological tests

Study 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Endothelial EVs quantification (EVs/mL) — 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) — 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.

Trial sites (1)

Facility	City	Region	Status
CHU de Saint-Etienne	Saint-Etienne	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06706102 on ClinicalTrials.gov ↗ ← All trials in France