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 atscreening 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.

Exclusion Criteria:

• Active infections such as hepatitis and tuberculosis.

• Other autoimmune diseases.

• Serious underlying diseases such as active malignancies, uncontrolled diabetes.

• Female subjects who were pregnant, breastfeeding.

• Any uncontrolled psychiatric disorders (e.g., schizophrenia, bipolar disorder,eating disorders, major depression or anxiety disorder), as declared by theparticipant or reported in the medical records.