Clinical trial NCT06706102: Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
Official title: Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Immune Effector Cell Associated Neurotoxicity Syndrome
Keywords: CAR-T Cell
ICANS
EVs
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Primary outcomes:
measure: Endothelial EVs quantification (EVs/mL)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: Endothelial EVs characterization (immunophenotyping)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Secondary outcomes:
measure: Other EV subtypes quantification (EV subtype/mL)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: Other EV subtypes characterization (immunophenotyping)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: EVS quantification according to the presence of an ICANS versus no ICANS (EV/mL)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: EVs characterization according to the presence of an ICANS versus no ICANS (immunophenotyping)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: EVs quantification according to levels of cytokines (EVs/mL)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: EVs characterization according to levels of cytokines
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: EVs quantification in cerebrospinal fluid (EVs/mL)
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: EVs characterization in cerebrosinalfluid.
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: Association of EVs subpopulations in clinical neurological damage and sleep apnea syndrome.
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: Association of EVs subpopulations in neuropsychological test and RMI.
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
measure: Cerabral involvement on RMI
timeFrame: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Emilie CHALAYER, MD
role: PRINCIPAL_INVESTIGATOR
References: