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.
Age range
18 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Proportion of participants with mRS score 0-2
Timeframe: Week 3 (±1 day), Week 4 (±1 day), Week 5 (±1 day), Week 6 (±1 day), Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Distribution of mRS scores
Timeframe: Week 3 (±1 day), Week 4 (±1 day), Week 5 (±1 day), Week 6 (±1 day), Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Proportion of participants with mRS improvement ≥1 point
Timeframe: Week 3 (±1 day), Week 4 (±1 day), Week 5 (±1 day), Week 6 (±1 day), Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Change in CASE score from baseline
Timeframe: Week 3 (±1 day), Week 4 (±1 day), Week 5 (±1 day), Week 6 (±1 day), Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Relapse rate within 48 weeks
Timeframe: Up to Week 48 (±10 days)