NCT06706102 Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
| NCT ID | NCT06706102 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Immune Effector Cell Associated Neurotoxicity Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-07-02 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant or breastfeeding woman, * Patient unable to understand informed consent, * Patient under legal protection.
Contact & Investigator
Emilie CHALAYER, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Frequently Asked Questions
Who can join the NCT06706102 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune Effector Cell Associated Neurotoxicity Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06706102 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06706102 currently recruiting?
Yes, NCT06706102 is actively recruiting participants. Contact the research team at emilie.chalayer@chu-st-etienne.fr for enrollment information.
Where is the NCT06706102 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT06706102 clinical trial?
NCT06706102 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Emilie CHALAYER, MD at Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 60 participants.