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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Diagnostic test
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Emilie CHALAYER, MD
emilie.chalayer@chu-st-etienne.fr
(0)4 77 82 28 14
Backup
Hélène RAINGARD
helene.raingard@chu-st-etienne.fr
(0)4 77 82 97 03
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2027-11
Participants
Target number of participants: 60
Treatments
Experimental: CAR T cell treatment
Major patients for whom CAR-T treatment is indicated.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov