Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
Trial Parameters
Brief Summary
This Phase 1, open-label study evaluates the safety, tolerability, and preliminary efficacy of RXIM002, a CD19-targeting circular RNA-mediated in-vivo CAR T-cell therapy, in adults with severe, relapsed, or refractory B cell-mediated autoimmune diseases.
Eligibility Criteria
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