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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Enrolling; Phase 4

Conditions: Immune Effector Cell Associated Neurotoxicity Syndrome

Treatments: Biological: Biological tests; Diagnostic Test: MRI; Diagnostic Test: Neuropsychological tests

Study type: Interventional

Funder types: Other

Identifiers

NCT06706102

24CH009

2024-515328-35-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

CAR T cell treatment

Experimental group

Description:

Major patients for whom CAR-T treatment is indicated.

Treatment:

Diagnostic Test: Neuropsychological tests

Diagnostic Test: MRI

Biological: Biological tests