OncoMatch/Clinical Trials/NCT06373211
Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
Is NCT06373211 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Immunoglobulins IV (CLAYRIG) and Cyclophosphamide IV for paraneoplastic sensory neuronopathy.
Treatment: Immunoglobulins IV (CLAYRIG) · Cyclophosphamide IV · Methylprednisolone IV — Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months.
Check if I qualifyExtracted eligibility criteria
Performance status
MODIFIED RANKIN SCORE 2–3
Prior therapy
Cannot have received: IVIg
More than two courses of IVIg administered within 3 months before recruitment
Cannot have received: immunotherapy
Other concomitant immunotherapy
Cannot have received: checkpoint inhibitor
Treatment with checkpoint inhibitors in progress or completed less than 3 months previously
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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