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Clinical Trials in China / NCT07051070
Starting soon Phase 4

Efficacy and Safety of Rituximab in the Treatment of Anti-Vimentin Antibody-associated Diseases

NCT07051070 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Phase 4
Started
2025-07-01
Last updated
2025-07-03

Condition(s) studied

Anti-Vimentin Antibody-associated DiseasesMeningoencephalomyelitis Associated With Vimentin IgG Autoantibodies

Investigational drug(s) / intervention(s)

RTX treatment

RTX treatment: This study used a drug dosage based on previous domestic and international literature as well as clinical experience from our center, set at 375mg/m2 per dose. During the course of the disease, TB lymphocyte subsets are monitored, and if the proportion of B lymphocytes is greater than or equal to 1%, a second dose will be administered.

Study summary

In 2025, a novel meningoencephalomyelitis associated with Vimentin IgG in cerebrospinal fluid (CSF) has been identified. Most patients exhibited progressive or recurrent episodes, characterized by prominent cerebellar ataxia, cranial nerve palsies, and pyramidal signs. The characteristic features included bilateral magnetic resonance imaging (MRI) lesions of the corticospinal tract, elevated CSF protein levels, and increased CSF cell counts. Despite receiving immunotherapy, these patients experienced significant disability.

This study employed a single-center, open-label, single-arm design to investigate the clinical efficacy and safety of rituximab (RTX) treatment in 40 patients with vimentin antibody (VIMA)-related diseases.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years, no gender restrictions; 2. Patients with positive CSF anti-Vimentin antibodies(VIMA), clinically consistent with the clinical features of VIMA-related diseases reported in JAMA Neurology 2024; 3. EDSS ≥ 3.5 points or evidence of disease activity as defined by the protocol within 1 year prior to screening. Evidence of disease activity as defined by the protocol: One of the following manifestations within 6 months of the screening period: 1. Enlargement of lesions on brain or spinal cord MRI T2 sequence; 2. △EDSS \> 0; 3. At least two FS scores increase by 1 point or at least 1 FS increases by 2 points (excluding rectal/bladder and brain); 4. Symptoms lasting for more than 24 hours without fever and more than 30 days since the last episode. 4. Sign informed consent. Exclusion Criteria: 1. Allergy to the study drug; 2. Known active infections during the screening period (excluding nail bed fungal infections or dental caries); 3. Underwent any surgical procedure within 4 weeks prior to screening, has evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy (PML); 4. Positive serology for HIV or syphilis treponema or RPR during the screening period (if syphilis antibodies are negative, further serological testing for syphilis is not required); 5. Chronic hepatitis B virus or hepatitis C virus infection that meets the following criteria: • HBsAg positive; • If HBsAg negative, HbcAb positive, further HBV DNA testing (result ≥1000 IU/mL); • If HCV antibody testing is positive, further HCV RNA testing (result above the upper limit of normal range at the research site); 6. Evidence of active tuberculosis (excluding patients receiving medication for latent TB infection); 7. Received any live vaccine or attenuated live vaccine within 6 weeks prior to the medication; 8. History of malignant tumors within 5 years prior to screening, including solid tumors, hematological malignancies, and carcinoma in situ (excluding fully resected and cured basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ); 9. Pregnant or breastfeeding women; for women of childbearing potential, a positive serum pregnancy test at screening, or unwilling to use reliable contraception (physical barriers \[patient or partner\] and spermicide, contraceptive pills, patches, injections, intrauterine devices or systems), and continuing for at least 4 months after the last administration of the study drug. Men of childbearing potential unwilling to use effective contraceptive measures during the period from signing the informed consent to 6 months after the last medication; 10. Any other diseases determined by the investigator that would make the subject unsuitable for participation in this study; 11. Presence of the following clinically significant diseases: 1. Echocardiography during the screening period shows a left ventricular ejection fraction (EF) below 50% or below the lower limit of normal values at the research center; history of chronic congestive heart failure, functional class NYHA III-IV; 2. Any of the following events occurred within 3 months prior to signing the informed consent: myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism, stroke; coronary revascularization surgery within 6 months; 3. Electrocardiogram during the screening period indicates QTc interval \>480ms (according to Fridericia's correction formula, where QTc=QT/RR\^0.33), or history of severe QTc interval prolongation; 12. Laboratory test values during the screening period show the following abnormalities: 1. Aspartate aminotransferase (AST) \> 3× upper limit of normal (ULN), alanine aminotransferase (ALT) \> 3× ULN, total bilirubin \> 1.5× ULN (unless due to Gilbert's syndrome); 2. Platelet count \<50,000/μL (or \<50 × 10\^9/L), hemoglobin \<9 g/dL (or \<90 g/L), white blood cells \<2.0 × 10\^3/μL, absolute neutrophil count \<1.0 × 10\^3/μL; 3. Creatinine clearance (CLcr) \<60 mL/min (calculated using the Cockcroft-Gault formula: \[140 - age (years)\] × \[weight (kg)\] × (0.85, if female) / \[72 × serum creatinine (mg/dL)\]) or undergoing dialysis during screening.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing China

More Xuanwu Hospital, Beijing trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07051070 on ClinicalTrials.gov ↗ ← All trials in China