Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases (NCT07322718) | Clinical Trial Compass
RecruitingEarly Phase 1
Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
China27 participantsStarted 2025-12-24
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Fulf…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of Dose-Limiting Toxicities (DLTs)
Timeframe: 28 days after RXIM002 first infusion (Day 1)
2
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timeframe: 52 weeks after RXIM002 first infusion (Day 1)
3
CAR positive cell Cmax
Timeframe: 24 weeks after RXIM002 first infusion (Day 1)
4
CAR positive cell Tmax
Timeframe: 24 weeks after RXIM002 first infusion (Day 1)
5
CAR positive cell AUC
Timeframe: 24 weeks after RXIM002 first infusion (Day 1)