New RNA therapy aims to tame Out-of-Control immune system
NCT ID NCT07322718
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new treatment called RXIM002 for people with severe autoimmune diseases that haven't responded to standard therapies. The treatment uses a special RNA molecule to create immune cells that target and destroy faulty B cells, which are causing the disease. The main goals are to check if the treatment is safe and to see how long the modified cells stay in the body. About 27 adults aged 18 to 65 with conditions like lupus are being enrolled.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital
RECRUITINGShanghai, Huangpu District, No. 197, Ruijin 2nd Road, China
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Other studies related to the condition(s) this trial covers.
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