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

Inclusion Criteria32

• 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.