NCT06706102

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
18mo left

Started Jul 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jul 2025Nov 2027

First Submitted

Initial submission to the registry

October 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

July 2, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

October 14, 2024

Last Update Submit

July 4, 2025

Conditions

Immune Effector Cell Associated Neurotoxicity Syndrome

Keywords

CAR-T CellICANSEVs

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (11)

  • Other EV subtypes quantification (EV subtype/mL)

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

  • Other EV subtypes characterization (immunophenotyping)

    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)

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

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

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

  • EVs quantification according to levels of cytokines (EVs/mL)

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

  • +6 more secondary outcomes

Study Arms (1)

CAR T cell treatment

EXPERIMENTAL

Major patients for whom CAR-T treatment is indicated.

Biological: Biological testsDiagnostic Test: MRIDiagnostic Test: Neuropsychological tests

Interventions

Biological testsBIOLOGICAL

Biological tests : cell quantification et characterization

CAR T cell treatment
MRIDIAGNOSTIC_TEST

MRI

CAR T cell treatment
Neuropsychological testsDIAGNOSTIC_TEST

Neuropsychological tests

CAR T cell treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or breastfeeding woman,
  • Patient unable to understand informed consent,
  • Patient under legal protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Study Officials

  • Emilie CHALAYER, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie CHALAYER, MD

CONTACT

(0)4 77 82 28 14emilie.chalayer@chu-st-etienne.fr

Hélène RAINGARD

CONTACT

(0)4 77 82 97 03helene.raingard@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

November 26, 2024

Study Start

July 2, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)