Actively Recruiting
Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
Led by Ruijin Hospital · Updated on 2026-01-23
27
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
R
RiboX Therapeutics Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to provide written informed consent
- Aged 18 to 65 years, any gender
- Adequate organ function as defined by screening tests
- Positive test for CD19 antigen
- Diagnosed with one of the following before screening: systemic lupus erythematosus (SLE), lupus nephritis (LN), systemic sclerosis (SSc), immune thrombocytopenia (ITP), idiopathic inflammatory myopathy (IIM), membranous nephropathy (MN), or autoimmune hemolytic anemia (AIHA)
- Active disease and evidence of disease activity according to specific autoimmune condition
- Fulfills relapsed or refractory status for their autoimmune disease
- For LN, a kidney biopsy indicating LN is required
- For ITP, platelet count less than 50 x 10⁹/L at screening
- Presence of disease-specific antibodies as appropriate for each condition
You will not qualify if you...
- Active infections such as hepatitis or tuberculosis
- Presence of other autoimmune diseases outside the specified conditions
- Serious underlying diseases including active cancers or uncontrolled diabetes
- Female participants who are pregnant or breastfeeding
- Uncontrolled psychiatric disorders such as schizophrenia, bipolar disorder, eating disorders, major depression, or anxiety disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Huangpu District, China, No. 197, Ruijin 2nd Road
Actively Recruiting
Research Team
Q
Qiongyi Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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