Autoimmune Encephalitis (AE)Phase 4NCT07686042
Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Refractory Autoimmune Encephalitis and Autoimmune Cerebellitis
A Phase 4 study testing Blinatumomab in people with Autoimmune Encephalitis (AE) and Autoimmune Cerebellitis, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis (AE), Autoimmune Cerebellitis
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years, male or female.
- Confirmed diagnosis of antibody-positive autoimmune encephalitis (AE) or autoimmune cerebellitis (ACA).
- Refractory AE/ACA defined as antibody-positive disease meeting all of the following:
- 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.
- Received additional immunotherapy beyond the first acute course, meeting the following:
Show all 32Show fewer
- For rituximab: treatment initiated at least 2 months prior to screening, last dose at least 4 weeks prior to baseline, and no improvement in mRS score for 2 months before baseline.
- For other immunosuppressive therapies (IST; e.g., mycophenolate mofetil, cyclophosphamide, azathioprine): treatment for at least 2 months prior to screening, stable dose for at least 4 weeks prior to baseline, and no improvement in mRS score for 4 weeks before baseline.
- For oral corticosteroids: stable dose >20 mg/day prednisone equivalent, no dose increase for 4 weeks prior to baseline, and no improvement in mRS score for 4 weeks before baseline.
- For repeated first-line therapy courses: completed at least 2 weeks prior to baseline visit.
- For patients on oral corticosteroids: stable dose ≥20 mg/day prednisone equivalent, no dose increase for 4 weeks prior to enrollment, and no improvement in mRS score for 4 weeks before enrollment.
- For patients on rituximab: treatment initiated at least 2 months prior to enrollment, last dose at least 4 weeks prior to enrollment, and no improvement in mRS score for 4 weeks before enrollment.
- For patients on other IST (e.g., azathioprine, mycophenolate mofetil): treatment for at least 2 months prior to enrollment, stable dose for at least 4 weeks prior to enrollment, and no improvement in mRS score for 4 weeks before enrollment.
- For patients on repeated first-line therapy courses: completed at least 2 weeks prior to enrollment.
- Patient or legally authorized representative provides written informed consent.
- For females of childbearing potential: agreement to abstain from heterosexual intercourse or use adequate contraception during treatment and for at least 3 months after the last dose. Post-menopausal females (≥12 consecutive months of amenorrhea without other cause) or those permanently sterilized by surgery (e.g., bilateral oophorectomy, hysterectomy) are not considered of childbearing potential. Acceptable contraceptive methods include bilateral tubal ligation, male sterilization, hormonal contraceptives, hormonal IUDs, copper IUDs, male/female condoms with spermicide, and contraceptive diaphragms/caps with spermicide. Periodic abstinence and withdrawal are not considered adequate.
- Diagnostic Criteria for Antibody-Positive Autoimmune Encephalitis (AE):
- Clinical presentation: Acute or subacute onset (<3 months) with ≥1 neuropsychiatric symptom:
- Limbic encephalitis: memory impairment, seizures, psychiatric symptoms.
- Encephalopathy syndrome: diffuse or multifocal brain dysfunction.
- CSF pleocytosis (>5×10⁶/L), lymphocytic inflammation, or oligoclonal bands.
- Investigations: ≥1 of the following or associated tumors:
- CSF abnormalities as above.
- Neuroimaging/EEG: MRI T2/FLAIR hyperintensity in limbic system or other regions (excluding non-specific white matter changes/stroke); PET hypermetabolism in limbic system or multifocal cortex/basal ganglia; EEG with focal epileptiform discharges or diffuse/multifocal slowing.
- Specific tumors associated with AE. C. Confirmatory test: Positive anti-neuronal antibodies. D. Other causes excluded. All criteria A-D must be met.
- Diagnostic Criteria for Autoimmune Cerebellitis (ACA):
- Acute or subacute onset with predominant cerebellar syndrome.
- No significant cerebellar/brainstem atrophy on brain MRI within 3 months of onset.
- Meets either 3.1 or 3.2:
- 3.1 Positive anti-cerebellar antibodies in serum and/or CSF detected by cell-based assay (CBA).
- 3.2 At least two of the following: personal or first-degree family history of autoimmune disease; CSF pleocytosis (>5×10⁶/L) or oligoclonal bands; characteristic immunofluorescence pattern of anti-Purkinje cell antibodies on tissue-based assay (TBA); presence of systemic autoimmune disease-related antibodies.
- Other causes excluded.
Who cannot join
- 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.
- Diseases requiring long-term corticosteroid or immunosuppressive therapy.
- Known history of primary immunodeficiency (congenital or acquired) or conditions predisposing to infection (e.g., HIV infection, splenectomy).
Show all 21Show fewer
- History of solid organ or hematopoietic stem cell transplantation within 3 months prior to screening.
- Live or attenuated vaccine within 3 weeks prior to enrollment (inactivated vaccines are allowed); BCG vaccine within 1 year prior to enrollment.
- Congenital heart disease, acute myocardial infarction within 6 months prior to screening, severe arrhythmias (e.g., polymorphic ventricular tachycardia), moderate to large pericardial effusion, severe myocarditis, hemodynamic instability requiring vasopressors, left ventricular ejection fraction (LVEF) ≤55%, or significant ECG abnormalities.
- Any of the following laboratory abnormalities:
- Absolute lymphocyte count (ALC) ≤0.5×10⁹/L
- Absolute neutrophil count (ANC) ≤0.5×10⁹/L
- Immunoglobulin G (IgG) ≤5.0 g/L
- CD4 T-cell count <300 cells/µL
- Hemoglobin ≤80 g/L
- Platelet count ≤75×10⁹/L
- Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m²
- AST/ALT ≥3× upper limit of normal (ULN); total bilirubin ≥2×ULN
- Pregnant or breastfeeding females, or those planning pregnancy during the trial.
- Incomplete medical records or refusal to participate in the registry.
- Known allergy or hypersensitivity to any component of the study drug or to any biologic therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Wangshu Xu, 13621017376, xuwangshu@mail.ccmu.edu.cn
About this study
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).
Read more
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.
- Being tested
- Blinatumomab
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Blinatumomab | Experimental | All enrolled patients in this arm will receive low-dose blinatumomab according to the study protocol. The treatment consists of 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 remains >1%, the dose may be optimized to 15 µg/m²/day (maximum 28 µg/day). Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with mRS score 0-2
Proportion of participants with modified Rankin Scale (mRS) score of 0 to 2 points at scheduled follow-up time points.
Measured: 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
Distribution of modified Rankin Scale (mRS) scores at scheduled follow-up time points.
Measured: 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
Proportion of participants with a decrease of ≥1 point in modified Rankin Scale (mRS) score from baseline at scheduled follow-up time points.
Measured: 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
Change in Clinical Assessment Scale for Autoimmune Encephalitis (CASE) score from baseline at scheduled follow-up time points.
Measured: 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
Relapse rate of autoimmune encephalitis and autoimmune cerebellitis within 48 weeks after treatment initiation.
Measured: Up to Week 48 (±10 days)
Secondary outcomes (7)
Changes in MMSE scores from baseline
Changes in Mini-Mental State Examination (MMSE) scores from baseline.
Measured: Week 3 (±1 day), Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Changes in MoCA scores from baseline
Changes in Montreal Cognitive Assessment (MoCA) scores from baseline.
Measured: Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Changes in PSQI scores from baseline
Changes in Pittsburgh Sleep Quality Index (PSQI) scores from baseline.
Measured: 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)
Changes in NPI scores from baseline
Changes in Neuropsychiatric Inventory (NPI) scores from baseline.
Measured: 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)
Changes in SDMT scores from baseline
Changes in Symbol Digit Modalities Test (SDMT) scores from baseline.
Measured: 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)
Changes in serum and CSF autoantibody titers from baseline
Changes in autoantibody titers in serum and cerebrospinal fluid (CSF) from baseline.
Measured: 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)
Changes in peripheral blood lymphocyte subsets from baseline
Changes in peripheral blood lymphocyte subsets from baseline at scheduled follow-up time points.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start24 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Encephalitis (AE)Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wangshu Xu, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686042
- Sponsor's protocol ID
- BTHospital
- Status last verified
- May 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Refractory Autoimmune Encephalitis and Autoimmune Cerebellitis
- ClinicalTrials.gov ID
- NCT07686042
- Acronym / sponsor ID
- BTHospital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 24 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Blinatumomab | Experimental | Drug: BlinatumomabAll enrolled patients in this arm will receive low-dose blinatumomab according to the study protocol. The treatment consists of 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 remains >1%, the dose may be optimized to 15 µg/m²/day (maximum 28 µg/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Aged ≥18 years, male or female.
- Confirmed diagnosis of antibody-positive autoimmune encephalitis (AE) or autoimmune cerebellitis (ACA).
- Refractory AE/ACA defined as antibody-positive disease meeting all of the following:
- 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.
Key exclusion criteria (21 listed)
- 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.
- Diseases requiring long-term corticosteroid or immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabLow-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). | Drug | Low-Dose Blinatumomab |
Primary outcome
Proportion of participants with mRS score 0-2
Time frame: 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 modified Rankin Scale (mRS) score of 0 to 2 points at scheduled follow-up time points.
Distribution of mRS scores
Time frame: 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 modified Rankin Scale (mRS) scores at scheduled follow-up time points.
Proportion of participants with mRS improvement ≥1 point
Time frame: 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 a decrease of ≥1 point in modified Rankin Scale (mRS) score from baseline at scheduled follow-up time points.
Change in CASE score from baseline
Time frame: 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 Clinical Assessment Scale for Autoimmune Encephalitis (CASE) score from baseline at scheduled follow-up time points.
Relapse rate within 48 weeks
Time frame: Up to Week 48 (±10 days)
Relapse rate of autoimmune encephalitis and autoimmune cerebellitis within 48 weeks after treatment initiation.
7 secondary outcomes
Changes in MMSE scores from baseline
Time frame: Week 3 (±1 day), Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Changes in MoCA scores from baseline
Time frame: Week 8 (±1 day), Week 12 (±1 day), Week 24 (±3 days), Week 36 (±5 days), Week 48 (±10 days)
Changes in PSQI scores from baseline
Time frame: 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)
Changes in NPI scores from baseline
Time frame: 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)
Changes in SDMT scores from baseline
Time frame: 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)
Changes in serum and CSF autoantibody titers from baseline
Time frame: 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)
Changes in peripheral blood lymphocyte subsets from baseline
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Autoimmune Encephalitis (AE)
Recruiting
OPM- MEG in Non-immune And iMmune-medIated Neurological Disease
Autoimmune Encephalitis (AE), Acute Disseminated Encephalomyelitis
Recruiting
Plasma Exchange in Pediatric Autoimmune Encephalitis
Autoimmune Encephalitis (AE)
Not yet recruitingPhase 2
A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
Autoimmune Encephalitis (AE)
RecruitingPhase 1
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD)
RecruitingEarly Phase 1
CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
Relapsing or Refractory Multiple Sclerosis (MS), Myasthenia Gravis (MG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wangshu Xu principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blinatumomab in people with Autoimmune Encephalitis (AE) and Autoimmune Cerebellitis, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wangshu Xu (+8613621017376, xuwangshu@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with mRS score 0-2 (time frame: 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.