💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 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.
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 the participant or reported in the medical records.
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