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;
Single group
ZM001 Injection
Biological/VaccineZM001 injection, 2.5× 10\^7 CAR-T cells, 5× 10\^7 CAR-T cells, 1× 10\^8 CAR-T cells and 2× 10\^8 CAR-T cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.
Incidence of Treatment Related adverse events (AEs)
Incidence of adverse events associated with ZM001 reinfusion within 28 days of ZM001 reinfusion, type, frequency, and severity of abnormal clinically significant vital signs, electrocardiograms, and laboratory tests examined, including dose-limiting toxicity
Lupus Low Disease Activity State (LLDAS)
Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at 12 weeks/24 weeks after ZM001 infusion
disease remission (DORIS)
Proportion of subjects achieving disease remission (DORIS) at 12 weeks/24 weeks after ZM001 infusion
SLEDAI-2K score
SLEDAI-2K score change from baseline values at 12 weeks/24 weeks after ZM001 infusion
British Isles Lupus Assessment Group Index (BILAG-2004)
British Isles Lupus Assessment Group Index (BILAG-2004) change from baseline values at 12 weeks/24 weeks after ZM001 infusion
Click on the lead sponsor to view all of their trials.
Beijing Immunochina Medical Science & Technology Co., Ltd.
Lead sponsor
Peking Union Medical College Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
