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

NCT07456358 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2026-04-09

Last updated

2026-07-07

Condition(s) studied

Neurological DiseasesAuto Immune Disease

Investigational drug(s) / intervention(s)

Lumbar puncture and blood sampling

Lumbar puncture and blood sampling: For all patients in the study, lumbar puncture will be performed as part of their care, according to the clinical indication given by the referring physician. If the patient gives their consent, an additional volume of CSF will be collected for this study, so that the total volume collected (care plus research) does not exceed 5 mL. No lumbar puncture will be performed specifically for the study. Blood samples will also be collected: these are additional blood tubes collected during a blood sample taken as part of the treatment (as described in the section 'Minimal risks and constraints added by the research').

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Presence of nervous system-specific TCRs in CSF of patients with ICI-related neurotoxicity — At day 1
Specific TCR repertoires of ICI-related neurotoxicity will be identified by TCR sequencing of CSF and blood lymphocytes of patients at the time of diagnosis of neurotoxicity of ICIs in comparison to those found in the control cohort 1.2. The target of these lymphocytes specifically found in cohort 1.1 will be assessed by EliSpot with known neuronal antigens as well as a search for serum and CSF onconeuronal autoantibodies. In silico methods as well as public TCR database will also be used to find the neurological targets.

Trial sites (4)

Facility	City	Region	Status
Hôpital Bicêtre AP-HP	Le Kremlin-Bicêtre	France	Recruiting
Fondation Rotschild	Paris	France	Not Yet Recruiting
Hôpital Saint Louis AP-HP	Paris	France	Recruiting
Hôpital Saint Louis	Paris	France	Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions Active, not recruiting

neonAtal motoR paTtErn autoMatIc analySis Recruiting

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis Recruiting

Effect of Adding Vasopressin on Cardiac Output, Blood Pressure, Diuresis, and Tissue Perfusion Indices in Patients With Septic Shock Starting soon

Efficacy of Methylprednisolone Pulses in Neuroendocrine Celles Hyperplasia of Infancy : An Early Phase Study Recruiting

Other trials for the same condition

Does Borrelia Burgdorferi Increases the Risk of Auto-immune Disease ? Active, not recruiting

Effect of a Weekly Yoga Program Integrated Into Standard Care on Disease Activity, Fatigue, Mood, and Treatment Adherence in Patients With Systemic Autoimmune and Inflammatory Diseases: A Prospective Observational Study Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07456358 on ClinicalTrials.gov ↗ ← All trials in France