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Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Refractory Autoimmune Encephalitis and Autoimmune Cerebellitis

NCT07686042 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

  • Autoimmune Encephalitis (AE)
  • Autoimmune Cerebellitis

Interventions

DRUG

Blinatumomab

Low-dose blinatumomab administered intravenously in two cycles: Cycle 1 (Week 1) at 9 μg/day for 5 consecutive days, and Cycle 2 (Week 3) at 9 μg/day for 5 consecutive days (45 μg per cycle). If no clinical improvement is observed at Week 3 and peripheral blood B-cell proportion (CD3-/CD19+) remains \>1%, the dose may be optimized to 15 µg/m²/day (maximum 28 µg/day).

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Wangshu Xu · Beijing Tiantan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-24
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686042 on ClinicalTrials.gov