A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases

The incidence of Dose-limiting toxicity (DLT)

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

The incidence, severity of Adverse events (AEs)

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.

The incidence, severity of Treatment-related Adverse event (TRAE)

An treatment-related adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which has a causal relationship with the treatment.

Maximum concentration (Cmax) in peripheral blood

Maximum concentration (Cmax) in peripheral blood

Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline for r/r SLE subjects

The SLEDAI-2K scale is a cumulative index used to assess disease activity across 24 different disease descriptors in patients with SLE. A total score ranges between 0 and 105, with a higher score representing a more significant degree of disease activity.

Change in IgG4-RD Response Index (IgG4-RD RI) from baseline for r/r IgG4-RD subjects

The IgG4-RD scale is a cumulative index used to assess disease activity across 25 different disease descriptions in patients with IgG4-RD. A total score ranges between 0 and 75, with a higher score representing a more significant degree of disease activity.

Change in Expanded Disability Status Scale (EDSS) scores from baseline for PMS subjects.

The EDSS is a scoring system used to quantify and monitor the progression of physical disability in patients with multiple sclerosis. The total score ranges from 0 to 10, with higher scores representing a worse outcome.

Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores from baseline for r/r MG subjects.

The MG-ADL is a patient-reported tool that quantifies the severity of myasthenia gravis symptoms based on daily functions. The total score ranges from 0 to 24, with higher scores representing a worse functional status.