RXIM002 for severe, relapsed or refractory B cell–mediated autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open‑label, single‑arm, dose‑escalation study gives adults with severe, relapsed or refractory B cell–mediated autoimmune diseases intravenous RXIM002 and follows them for safety and biological response. Participants will be monitored for adverse events, laboratory measures, pharmacokinetics, pharmacodynamics, and immunogenicity, and investigators will look for preliminary signs of clinical improvement. The protocol includes screening, treatment, and follow‑up periods to capture both short‑term safety and longer‑term durability of any effects. Dosing is escalated in sequential cohorts to determine tolerability and an appropriate dose range.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital
  Shanghai, Huangpu District, China Recruiting

Study contacts

• Study coordinator: Qiongyi Hu
• Email: huqiongyi131@163.com
• Phone: +86 021-50199835

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.