Temporal characterization of Extracellular Vesicles during cellular therapy using CAR-T cells and during the occurrence of Immune effector Cell-Associated Neurotoxicity Syndrome : the VESICANS study

Conditions

hematology

Brief summary

Quantification and characterization endothelial EVs.

Detailed description

Quantification and characterization of other EVs subtypes as a function of time before and after treatment with CAR-T cells according to ICANS grade., Quantification and characterization of EVs according to the presence of an ICANS versus no ICANS., Quantification and characterization of EVs according to levels of cytokines., Quantification and structural and molecular characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available., Characterization of the association of subpopulations of EVs according to clinical neurological impairment and the presence or absence of a sleep apnea syndrome., Characterization of the association of EVS subpopulations according to cognitive assessment and MRI before lymphodepleting chemotherapy and at the time of ICANS., Description of involvement on MRI before lymphodepleting chemotherapy and at the time of ICANS.

Related papers

No related papers found yet.

Interventions

DRUGBreyanzi 1.1-70 × 106 cells/mL / 1.1-70 × 106 cells/mL dispersion for infusion

DRUGYESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion

DRUGAbecma 260 - 500 x 10^6 cells dispersion for infusion

DRUGGADOVIST 1

DRUG0 mmol/mL

DRUGsolution injectable

DRUGKymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion

DRUGTecartus 0.4 - 2 x 10e8 cells dispersion for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Quantification and characterization endothelial EVs.	—

Secondary

Measure	Time frame
Quantification and characterization of other EVs subtypes as a function of time before and after treatment with CAR-T cells according to ICANS grade., Quantification and characterization of EVs according to the presence of an ICANS versus no ICANS., Quantification and characterization of EVs according to levels of cytokines., Quantification and structural and molecular characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available., Characterization of the association of subpopulations of EVs according to clinical neurological impairment and the presence or absence of a sleep apnea syndrome., Characterization of the association of EVS subpopulations according to cognitive assessment and MRI before lymphodepleting chemotherapy and at the time of ICANS., Description of involvement on MRI before lymphodepleting chemotherapy and at the time of ICANS.	—

Measure

Time frame

Quantification and characterization of other EVs subtypes as a function of time before and after treatment with CAR-T cells according to ICANS grade., Quantification and characterization of EVs according to the presence of an ICANS versus no ICANS., Quantification and characterization of EVs according to levels of cytokines., Quantification and structural and molecular characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available., Characterization of the association of subpopulations of EVs according to clinical neurological impairment and the presence or absence of a sleep apnea syndrome., Characterization of the association of EVS subpopulations according to cognitive assessment and MRI before lymphodepleting chemotherapy and at the time of ICANS., Description of involvement on MRI before lymphodepleting chemotherapy and at the time of ICANS.

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Countries

France

Outcome results

None listed