This is a multicenter, single-arm, continuous, prospective, interventional registry study designed to systematically evaluate the efficacy and safety of low-dose blinatumomab in patients with antibody-mediated refractory autoimmune encephalitis (AE) and autoimmune cerebellitis. Eligible participants will be patients with a confirmed diagnosis of refractory AE or autoimmune cerebellitis who have provided written informed consent. All enrolled patients will receive blinatumomab treatment according to a unified protocol, consisting of two cycles:
Cycle 1 (Week 1): Continuous intravenous infusion at 9 µg/day for 5 consecutive days (total dose: 45 µg).
Cycle 2 (Week 3): Continuous intravenous infusion at 9 µg/day for 5 consecutive days (total dose: 45 µg). If there is no improvement in the modified Rankin Scale (mRS) score at Week 3 and the proportion of peripheral blood B cells (CD3-/CD19+) remains \>1%, the dose may be optimized to 15 µg/m²/day (maximum 28 µg/day).
During the study, all patients will undergo regular follow-up visits to collect data on clinical symptoms, functional scores, immunological biomarkers, and adverse events, to comprehensively assess the efficacy and safety of the treatment. This study uses a non-randomized, open-label design with no blinding or control group.
Aged ≥18 years, male or female.
Confirmed diagnosis of antibody-positive autoimmune encephalitis (AE) or autoimmune cerebellitis (ACA).
Modified Rankin Scale (mRS) score >3 (stable for at least 24 hours) at baseline.
Received first-line acute therapy more than 6 weeks prior to baseline visit, defined as at least 3 days of intravenous methylprednisolone (≥500 mg/day) or equivalent oral corticosteroids, and/or at least 3 days of IVIG and/or plasma exchange (PE), or any combination thereof.
Systemic or central nervous system tumors (e.g., gliomatosis cerebri), history of cancer (excluding ovarian/extra-ovarian teratoma, skin squamous cell carcinoma, or basal cell carcinoma with documented cure ≥3 months prior to enrollment); hereditary diseases (e.g., mitochondrial encephalopathy); neurodegenerative diseases (e.g., Lewy body dementia); prior epilepsy with ongoing seizures; severe traumatic brain injury; metabolic/toxic encephalopathy (e.g., Wernicke encephalopathy).
Infectious diseases (e.g., viral encephalitis); active or uncontrolled infection requiring systemic treatment within 1 week prior to screening; history of severe recurrent or chronic infections, especially respiratory infections.
Positive hepatitis B surface antigen/核心 antigen and/or positive hepatitis C PCR at screening.
Active tuberculosis at screening.