Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases

Up to 120 subjects with B-cell mediated autoimmune rheumatic diseases will be enrolled in a single-arm, open-label, single-site Phase 1 study. The study includes 2 parts. The first Part A is an establishment of the safety profile followed by a dose ranging, maximum tolerated dose (MTD) study and the second Part B is an extension phase to further evaluate safety at the selected safe dose. Eligible subjects will undergo leukapheresis procedure to provide starting material for manufacturing of HBI0101 CART investigational product. Each eligible subject will receive a single dose of HBI0101 CART cells. Prior to administration of HBI0101 CART, the study subjects will undergo lymphodepletion. Following administration of HBI0101 CART the subjects will be hospitalized for several days and then will return for routine follow-up periodical visits until 48 months after infusion.