Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases

Inclusion Criteria

• •Subjects voluntary agreement to provide written informed consent.
• •Aged 18 to 65 years, either sex.
• •Adequate organ function meeting screening criteria.
• •Positive test for cluster of differentiation antigen 19 (CD19).
• •Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN):
• •Have been diagnosed with SLE or LN before screening.
• •Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), antinuclear antibody (ANA), or anti-Sm antibodies at screening.
• •Active disease at screening.
• •Fulfill relapsed/refractory SLE or LN conditions
• •Lupus Nephritis (LN) :
• •Kidney biopsy result indicating LN
• •Evidence of LN disease activity
• •Systemic Sclerosis (SSc):
• •Have been diagnosed with SSc before screening.
• •Antinuclear Antibody (ANA) positive at screening or prior to screening. AND, evidence of SSc disease activity.
• •Fulfill relapsed/refractory SSc conditions.
• •Immune Thrombocytopenia (ITP):
• •Have been diagnosed with refractory ITP before screening.
• •Platelet count \<50×10⁹/L at screening.
• •Idiopathic Inflammatory Myopathy (IIM):
• •Have been diagnosed with IIM before screening.
• •Presence of at least 1 myositis specific (MSA), associated antibody (MAA), or ANA at screening or prior to screening.
• •Evidence of IIM disease activity.
• •Fulfill relapsed/refractory IIM conditions.
• •Membranous Nephropathy (MN):
• •Have been diagnosed with MN before screening.
• •Active MN patients meeting screening criteria.
• •Fulfill relapsed/refractory MN conditions.
• •Autoimmune Hemolytic Anemia (AIHA):
• •Have been diagnosed with AIHA before screening.
• •Active AIHA patients meeting screening criteria.
• •Fulfill relapsed/refractory AIHA conditions.