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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515328-35-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR T cell treatment | Experimental | Major patients for whom CAR-T treatment is indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological tests | Biological | Biological tests : cell quantification et characterization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| 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. | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| Other EV subtypes characterization (immunophenotyping) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie CHALAYER, MD | Contact | (0)4 77 82 28 14 | +33 | emilie.chalayer@chu-st-etienne.fr |
| Hélène RAINGARD | Contact | (0)4 77 82 97 03 | +33 | helene.raingard@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emilie CHALAYER, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
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| MRI | Diagnostic Test | MRI |
|
| Neuropsychological tests | Diagnostic Test | Neuropsychological tests |
|
Other EV subtypes characterization of as a function of time before and after treatment with CAR-T cells according to ICANS grade. |
| Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| 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 | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| 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 | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| EVs quantification according to levels of cytokines (EVs/mL) | EVs quantification according to levels of cytokines | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| EVs characterization according to levels of cytokines | EVs characterization according to levels of cytokines | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| EVs quantification in cerebrospinal fluid (EVs/mL) | EVs quantification after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available. | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| EVs characterization in cerebrosinalfluid. | EVs characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available. | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| Association of EVs subpopulations in clinical neurological damage and sleep apnea syndrome. | Characterization of the association of subpopulations of EVs according to clinical neurological damage and sleep apnea syndrome. | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| Association of EVs subpopulations in neuropsychological test and RMI. | Characterization of the association of subpopulations of EVs according to neuropsychological test and RMI. | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |
| Cerabral involvement on RMI | Diffusion tensor imaging and resting state default mode network | Days -7, 0, 1, 2, 5, 8, 15, 30 and 60 |