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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

Study acronym: VESICANS
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 2 entries Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 4 of 11 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 4 of 11 entries
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2025 to Jul 2, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2025 to Jul 2, 2025
    • Site details revised
  3. Start date: Mar 2025 to Jun 2025v3
  4. Start date: Jan 2025 to Mar 2025v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06706102
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Conditions Immune Effector Cell Associated Neurotoxicity Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov