A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus
All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
Be over 18 years of age, male or female;
A diagnosis of SLE according to the 2012 systemic lupus international collaborating clinics(SLICC);
Conventional regimens for SLE are corticosteroids and one or more immunomodulatory drugs over 6 months；
Severe lupus nephritis (defined as proteinuria > 6 g/24h or serum creatinine > 2.5 mg/dL or 221 μmol/L), treatment with active nephritis with Prohibited drugs, hemodialysis, or prednisone ≥100 within 8 weeks prior to screening mg/d or equivalent glucocorticoid therapy ≥14 days.
Prior to screening, other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.
Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
Combined with other autoimmune diseases, systematic treatment is needed.
Sequential
Metabolically Armed CD19 CAR-T cells
DrugEach subject receive metabolically armed CD19 CAR- T cells by intravenous infusion
MTD
Determine the Maximal Tolerable Dose(MTD).
DCR
Disease control rates (DCR) assessed according to SLEDAI-2000, Physician Overall Assessment (PGA), and medication.
Concentration of CAR-T cells
Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion.
Pharmacodynamics of CAR-T cells
Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, INF-γ at each time point.
Autoantibody detection
Concentration levels of B cell related serum antibodies such as complement factor C3 , ANA, anti-dsDNA each time point.
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Zhejiang University
Lead sponsor
Leman Biotech Co., Ltd.
Collaborator
