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Tests treatment safety and results for Relapsed/Refractory B Cell-Mediated Autoimmune Diseases
Official title Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07322718
What this study is testing
What is RXIM002 product?
RXIM002 product is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory b cell-mediated autoimmune diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people 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.
You likely can't join if
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as active malignancies, uncontrolled diabetes.
- Female people who were pregnant, breastfeeding.
- Any uncontrolled psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, major depression or anxiety disorder), as declared...
See the full eligibility criteria
- people 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.
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as active malignancies, uncontrolled diabetes.
- Female people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Huangpu District, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Huangpu District, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.