A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.

DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.

CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.

RP2D established through dose exploratory.

The SELENA-2K scale is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-2K total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.

The physician will place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (Score 0) represents "no activity", and the right-hand boundary (score 3) represents "the most severe activity".

Percentage of participants achieving the LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (Central nervous system, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) Physician global assessment (PGA) (score 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg dailyultiple visits.

Proteinuria will be assessed in lupus nephritis patients basing on 24h urinary protein/UPCR at multiple visits.

Detection of Immunoglobulins, anti-drug antibodies (anti-dsDNA antibody, anti-Sm antibody, etc.) and anti-drug antibody.