Autoimmune Neurological Diseases and Those Secondary to Immunotherapy: Study of Immunological Mec… (NCT07456358) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Autoimmune Neurological Diseases and Those Secondary to Immunotherapy: Study of Immunological Mechanisms and Research Into Targets of Immune Attack
160 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Presence of nervous system-specific TCRs in CSF of patients with ICI-related neurotoxicity