Autoimmune Neurological Diseases and Those Secondary to Immunotherapy: Study of Immunological Mechanisms and Research Into Targets of Immune Attack

Recruiting now · Not applicable

Conditions studied: Neurological Diseases, Auto Immune Disease

In brief

The pathophysiology of neurological toxicities secondary to immune checkpoint inhibitors (ICIs) is unknown. Various mechanisms have been proposed: activation of cytotoxic CD8 T cells, autoantibodies via activation of B cells and CD4 cells, non-specific inflammation through the production of pro-inflammatory cytokines, and complement activation. The aim of this research is to characterise the pathophysiological mechanisms of neurotoxicities in cancer patients treated with ICIs.

Key facts

Study ID

NCT07456358

Run by

Assistance Publique - Hôpitaux de Paris

People needed

160

Starts

2026-04-09

Expected to finish

2030-12-09

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Hôpital Bicêtre AP-HP — Le Kremlin-Bicêtre, France (enrolling)
• Hôpital Saint Louis AP-HP — Paris, France (enrolling)
• Hôpital Saint Louis — Paris, France (enrolling)
• Fondation Rotschild — Paris, France

Full record on ClinicalTrials.gov

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