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

Recruiting now · Early Phase 1

Conditions studied: Relapsed/Refractory B Cell-Mediated Autoimmune Diseases

In brief

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.

Key facts

Study ID

NCT07322718

Run by

Ruijin Hospital

People needed

27

Starts

2025-12-24

Expected to finish

2028-03-19

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):

You may not qualify if…

• 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 the participant or reported in the medical records.

Where it is running

• Ruijin Hospital — Shanghai, Huangpu District, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.