Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
Recruiting
Phase 4
Interventional Study
Immune Effector Cell Associated Neurotoxicity Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 60 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Other
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About This Trial
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 (…
Trial Locations
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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 …
Contacts