Autoimmune neurological diseases and neurotoxicity after immunotherapy: uncovering immune attack mechanisms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study plans to collect blood and cerebrospinal fluid samples from adults treated with immune checkpoint inhibitors who develop new neurological symptoms, as well as from patients with related autoimmune CNS conditions or idiopathic intracranial hypertension. Researchers aim to characterize the immune mechanisms driving neurotoxicity, including T cell activity, autoantibodies, and inflammatory mediators. The approach centers on identifying immunological signatures that may distinguish drug-related neurotoxicity from other neurological diseases. The findings could inform future strategies to prevent or manage these adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patient (aged ≥ 18 years)
* Affiliated with a social security scheme
* Express consent to participate in the study
* Indication for lumbar puncture And
* Patients with cancer, undergoing treatment with ICIs, presenting neurological symptoms after starting treatment with ICIs. These symptoms must have appeared no more than 3 months after the last administration of ICIs.

Or

* Patients with an autoimmune disease of the central nervous system (diagnosis made by teams 1, 2 and 3) according to internationally recognised criteria, with no history of active cancer in the last 3 years and no other autoimmune disease Or
* Patients with normal pressure hydrocephalus (NPH) or idiopathic intracranial hypertension (diagnosed based on imaging (brain MRI) and clinical findings), with no history of active cancer in the last 3 years and no active autoimmune disease

Exclusion Criteria:

* Contraindication or refusal to perform a lumbar puncture
* Sample not suitable for research (volume of CSF collected for treatment \>5 mL)
* Corticosteroid therapy or other immunomodulatory treatment in progress (discontinued less than 15 days prior to inclusion)
* Pregnant or breastfeeding women
* Not affiliated with the social security system, patients under French State Medical Aid for undocumented migrants
* Patients under guardianship or curatorship, under judicial protection measures, or deprived of their liberty by judicial or administrative decision

Where it's running

• Hôpital Bicêtre AP-HP
  Le Kremlin-Bicêtre, France Recruiting
• Hôpital Saint Louis AP-HP
  Paris, France Recruiting
• Hôpital Saint Louis
  Paris, France Recruiting
• Fondation Rotschild
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Stefania Cuzzubbo, MD
• Email: stefania.cuzzubbo@aphp.fr
• Phone: 0171207467

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.