Clinical Trials in China / NCT07322718
Recruiting
Early Phase 1
Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
NCT07322718 · tracked via the Priya Life Science China tracker
Condition(s) studied
Relapsed/Refractory B Cell-Mediated Autoimmune Diseases
Investigational drug(s) / intervention(s)
RXIM002 product
RXIM002 product: Prior to infusion of the RXIM002 product, subjects will receive pre-medication if needed
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Incidence and severity of Dose-Limiting Toxicities (DLTs) — 28 days after RXIM002 first infusion (Day 1)
- Incidence and severity of treatment-emergent adverse events (TEAEs) — 52 weeks after RXIM002 first infusion (Day 1)
- CAR positive cell Cmax — 24 weeks after RXIM002 first infusion (Day 1)
CAR positive T cells in peripheral blood after RXIM002 infusion, maximum concentration (Cmax). - CAR positive cell Tmax — 24 weeks after RXIM002 first infusion (Day 1)
CAR positive T cells levels in peripheral blood after RXIM002 infusion, time to Cmax (Tmax). - CAR positive cell AUC — 24 weeks after RXIM002 first infusion (Day 1)
CAR positive T cells levels in peripheral blood after RXIM002 infusion, area under the concentration-time curve (AUC) .
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruijin Hospital | Shanghai | Huangpu District | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07322718 on ClinicalTrials.gov ↗ ← All trials in China