Characterizing extracellular vesicles and blood–brain barrier changes during CAR‑T therapy to understand ICANS
Official title: Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
Run by Centre Hospitalier Universitaire de Saint Etienne · NCT06706102 · Data updated 2026-11-12
This research will try to see if tracking extracellular vesicles in blood and MRI markers of blood–brain barrier change can help detect or explain ICANS in adults receiving CAR‑T cell therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Saint-Etienne) |
| Status | Recruiting |
| Started | July 2, 2025 |
| Main results expected | September 2027 |
| Study ends | November 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT06706102 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) who are scheduled to receive CAR‑T cell therapy at CHU de Saint‑Etienne, can give informed consent, and are affiliated with a social security system are ideal candidates.
✕Probably not a fit
Patients who are not receiving CAR‑T therapy, as well as pregnant or breastfeeding individuals, those unable to consent, or those under legal protection will not be eligible and therefore will not directly benefit from this protocol, and patients whose ICANS arises from mechanisms unrelated to extracellular vesicles may also see no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
VESICANS will enroll adults receiving clinically indicated CAR‑T therapy at CHU de Saint‑Etienne and collect serial blood samples before treatment, during therapy, and at the onset of any ICANS. Extracellular vesicles will be profiled using flow cytometry, electron microscopy, and nanoparticle tracking analysis, while MRI will assess blood–brain barrier integrity and neuropsychological tests will monitor cognitive and neurological status. The study will correlate temporal changes in EV populations and imaging markers with the timing and severity of ICANS. Findings aim to identify biomarkers or mechanisms that could inform earlier detection or prevention of this neurotoxicity.
Why it matters
Potential benefit: If successful, this work could enable earlier detection of ICANS or point to new prevention strategies that reduce neurological harm from CAR‑T therapy.
How similar studies have gone: Preliminary human and animal data suggest extracellular vesicles change with neuroinflammation, but this specific temporal, multimodal characterization around ICANS is largely novel and unproven.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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CHU de Saint-Etienne
Saint-Etienne, France Recruiting
Study contacts
- Principal investigator: Emilie CHALAYER, MD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Emilie CHALAYER, MD
- Email: emilie.chalayer@chu-st-etienne.fr
- Phone: (0)4 77 82 28 14
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.