This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.
18-90 years old;
Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria.
SELENA-SLEDAI≥8.
Patients with CD19+ B-cell.
Renal disease: severe lupus nephritis (serum creatinine > 2.5 mg/dL or 221 μmol/L) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.
CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.
Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.
Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;