This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus
Subjects with a diagnosis of systemic lupus erythematosus according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria;
Adequate standard therapeutic doses of glucocorticoids, immunosuppressants, and at least one biologic therapy combination regimen for at least 2 months prior to screening are required, and the dose is stable for >2 weeks and the disease remains moderately to severely active.
Immunosuppressants: at least one or more of cyclophosphamide, mycophenolic acids, azathioprine, and calcineurin phosphatase inhibitors have been used;
Biologics: at least one or more of belimumab, tetracycline, rituximab;
Pre-existing or clinically significant CNS disorders not due to lupus at the time of screening, such as convulsive seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, encephalitis, CNS vasculitis, or psychiatric disorders; epilepsy due to lupus, stable without seizures for a period of 1 year prior to the screening period Stable seizure-free for 1 year may also be screened.
Treatment with hemodialysis, or high-dose corticosteroids (prednisone ≥1.5 mg/kg/d or equivalent glucocorticoid therapy for ≥14 days) was required within 2 months prior to screening.
Presence of still uncontrolled lupus crisis within 2 months prior to screening that is assessed by the investigator to be unsuitable for participation in this study;
Massive plasmapheresis (e.g., pleural effusion, abdominal effusion) with symptoms of compression that cannot be controlled with treatment;
Beijing Immunochina Medical Science & Technology Co., Ltd.
Lead sponsor
Peking Union Medical College Hospital
Collaborator