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

ConditionImmune Effector Cell Associated Neurotoxicity Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or breastfeeding woman,

Patient unable to understand informed consent,

Patient under legal protection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biological tests

    Biological/Vaccine

    Biological tests : cell quantification et characterization

  • MRI

    Diagnostic test

    MRI

  • Neuropsychological tests

    Diagnostic test

    Neuropsychological tests

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: CAR T cell treatmentExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Endothelial EVs quantification (EVs/mL)

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.

Time frame
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
2

Endothelial EVs characterization (immunophenotyping)

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.

Time frame
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60

Secondary outcomes

1

Other EV subtypes quantification (EV subtype/mL)

Other EV subtypes quantification of as a function of time before and after treatment with CAR-T cells according to ICANS grade.

Time frame
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
2

Other EV subtypes characterization (immunophenotyping)

Other EV subtypes characterization of as a function of time before and after treatment with CAR-T cells according to ICANS grade.

Time frame
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
3

EVS quantification according to the presence of an ICANS versus no ICANS (EV/mL)

EVS quantification according to the presence of an ICANS versus no ICANS

Time frame
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
4

EVs characterization according to the presence of an ICANS versus no ICANS (immunophenotyping)

EVS characterization of EVs according to the presence of an ICANS versus no ICANS

Time frame
Days -7, 0, 1, 2, 5, 8, 15, 30 and 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Source ClinicalTrials.gov
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