NCT07322718 Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
| NCT ID | NCT07322718 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Ruijin Hospital |
| Condition | Relapsed/Refractory B Cell-Mediated Autoimmune Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-12-24 |
| Primary Completion | 2027-12-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2025-12-24 with a primary completion date of 2027-12-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07322718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Relapsed/Refractory B Cell-Mediated Autoimmune Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07322718 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07322718 currently recruiting?
Yes, NCT07322718 is actively recruiting participants. Contact the research team at huqiongyi131@163.com for enrollment information.
Where is the NCT07322718 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07322718 clinical trial?
NCT07322718 is sponsored by Ruijin Hospital. The trial plans to enroll 27 participants.