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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

RY_SW01 Cell Injection Therapy in Active Lupus Nephritis

A Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of RY_SW01cell Injection Therapy in Active Lupus Nephritis

RY_SW01 Cell Injection Therapy in Active Lupus Nephritis (NCT06058078) is a Phase 2 interventional studying Lupus Nephritis, sponsored by Jiangsu Renocell Biotech Company. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

RY\_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no occurrence of rejection and excellent safety. The mechanism of action of RY\_SW01 Cell Injection is relatively clear, demonstrating favorable therapeutic effects in preclinical animal models. Compared to existing conventional therapies, it has the advantages of "convenient treatment and sustained efficacy." It may help reduce the variety and quantity of drugs administered to patients and the various side effects associated with drug treatment. In some cases, it may even lead to the discontinuation of immunosuppressive drugs, reducing mortality and disability rates while improving the quality of life for patients. Its unique advantages have the potential to fundamentally change the current clinical treatment landscape and offer promising prospects for clinical application.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Lupus Nephritis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Lupus Nephritis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily sign an willing to sign a consent form form. 2. Male or female aged ≥18 and ≤65 years. 3. Medical history indicating the fulfillment of at least 4 out of the 11 SLE classification criteria recommended by the American College of Rheumatology (ACR) in 1997, with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≥6. 4. Previous receipt of induction therapy (combination of steroids with immunosuppressants, biologics, or two or more treatments), as determined by the investigator, and the participant demonstrated intolerance to or lack of response to this treatment. 5. Confirmed diagnosis of class III or class IV lupus nephritis according to the ISN/RPS classification criteria (Class III(A), Class III(A+C), Class IV(A), or Class IV(A+C)), with the possibility of being combined with Class V or isolated Class V (including activity and chronicity indices). 6. Laboratory examination showing a urinary protein-to-creatinine ratio (UPCR) \> 1000 mg/g or 100 mg/mmol or \> 1.0. 7. During the trial and for at least 1 year after injection administration, the participant has no plans for pregnancy and voluntarily agrees to use effective contraception with their partner (see Appendix 1) and has no plans for sperm or egg donation. Who Should NOT Join This Trial: 1. Severe liver dysfunction with any of the following abnormalities: total bilirubin \> 2 times the upper limit of normal (ULN); ALT or AST \> 2 times the ULN. 2. Severe kidney dysfunction with eGFR \< 30 mL/min/1.73m² or serum creatinine \> 265.2 µmol/L. 3. Kidney biopsy pathology indicating ≥50% glomerulosclerosis. 4. Blood system abnormalities with any of the following abnormalities: white blood cell count \< 2000/µL (2×10\^9/L), hemoglobin \< 6g/dL (60g/L), platelet count \< 30000/µL (30×10\^9/L), neutrophils \< 1000/µL (1×10\^9/L). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Voluntarily sign an informed consent form. 2. Male or female aged ≥18 and ≤65 years. 3. Medical history indicating the fulfillment of at least 4 out of the 11 SLE classification criteria recommended by the American College of Rheumatology (ACR) in 1997, with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≥6. 4. Previous receipt of induction therapy (combination of steroids with immunosuppressants, biologics, or two or more treatments), as determined by the investigator, and the participant demonstrated intolerance to or lack of response to this treatment. 5. Confirmed diagnosis of class III or class IV lupus nephritis according to the ISN/RPS classification criteria (Class III(A), Class III(A+C), Class IV(A), or Class IV(A+C)), with the possibility of being combined with Class V or isolated Class V (including activity and chronicity indices). 6. Laboratory examination showing a urinary protein-to-creatinine ratio (UPCR) \> 1000 mg/g or 100 mg/mmol or \> 1.0. 7. During the trial and for at least 1 year after injection administration, the participant has no plans for pregnancy and voluntarily agrees to use effective contraception with their partner (see Appendix 1) and has no plans for sperm or egg donation. Exclusion Criteria: 1. Severe liver dysfunction with any of the following abnormalities: total bilirubin \> 2 times the upper limit of normal (ULN); ALT or AST \> 2 times the ULN. 2. Severe kidney dysfunction with eGFR \< 30 mL/min/1.73m² or serum creatinine \> 265.2 µmol/L. 3. Kidney biopsy pathology indicating ≥50% glomerulosclerosis. 4. Blood system abnormalities with any of the following abnormalities: white blood cell count \< 2000/µL (2×10\^9/L), hemoglobin \< 6g/dL (60g/L), platelet count \< 30000/µL (30×10\^9/L), neutrophils \< 1000/µL (1×10\^9/L). 5. Severe and uncontrolled cardiovascular diseases, neurological disorders, pulmonary diseases (including obstructive lung disease and interstitial lung disease), liver diseases, endocrine disorders (including uncontrolled diabetes), and gastrointestinal diseases, including but not limited to: * Patients with uncontrolled severe hypertension (≥160/100 mmHg). * Patients with uncorrected heart failure or severe heart dysfunction (NYHA class ≥III). * Patients with a history of myocardial infarction within the previous 6 months or meet the diagnostic criteria for acute myocardial infarction at screening. * Patients with a history of acute stroke within the previous 6 months or at risk of acute cerebrovascular events at screening. * Patients with a history of severe pulmonary hypertension. * Patients with severe arrhythmias (e.g., rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia). 6. Patients with a history of IgA deficiency (IgA \< 10 mg/dL). 7. Patients with other autoimmune diseases except for SLE, including dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, etc., should be excluded. However, patients with secondary Sjögren's syndrome are allowed to participate in this trial. 8. Received live vaccines or attenuated live vaccines within the previous 12 weeks or expect to receive/require live vaccines during the trial. 9. Underwent plasmapheresis or immunoadsorption therapy within the previous 24 weeks or received intravenous immunoglobulin (IVIG) therapy within the previous 4 weeks. 10. Used other investigational drugs within the previous 12 weeks. 11. Tested positive for human immunodeficiency virus antibodies (anti-HIV-Ab) during screening, active syphilis, active hepatitis C (positive for hepatitis C antibodies, and HCV-RNA higher than the lower limit of detection), or positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA (HBV-DNA ≥500 IU/ml). History of severe active or recurrent bacterial, viral, fungal, parasitic, or other infections during the screening period. 12. History of malignant tumors within the past 5 years, including solid tumors, hematological malignancies, or in situ cancers (except for surgically removed or cured basal cell carcinoma of the skin). 13. Underwent any major surgery within the previous 12 weeks or anticipated to undergo major surgery during the trial, which is considered to pose an unacceptable risk to the participant by the investigator. 14. Intolerance or contraindication to the treatment protocol of this trial, including any of the following conditions: * History of allergies to allogeneic mesenchymal stem cells or excipients (including human albumin). * Intolerance or contraindication to oral or intravenous corticosteroids. * Absence of peripheral venous access. 15. Pregnant or lactating women. 16. Within the previous 12 months or during the screening period, there is evidence of smoking, alcohol misuse, or drug abuse, defined as follows: * Smoking defined as an average daily smoking of ≥5 cigarettes within the previous 3 months. * Alcohol misuse defined as consuming more than 14 units of alcohol per week within the previous 3 months (1 unit of alcohol = 350 ml of beer, or 45 ml of spirits, or 150 ml of wine). * Drug abuse defined as a positive result in urine drug screening or having a history of drug abuse. 17. Participants judged by the investigator as not suitable for participation in this trial will be excluded.

Treatments Being Tested

DRUG

RY_SW01 cell injection

Injected RY\_SW01 allogonic umbilical cord-derived mesenchymal stem cells(UCMSCs)

DRUG

Basic treatment

Drugs for LN treatment

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

the Affiliated Drum Tower Hospital, Medical School, Nanjing University
Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06058078), the sponsor (Jiangsu Renocell Biotech Company), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06058078 clinical trial studying?

RY\_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no occurrence of rejection and excellent safety. The mechanism of action of RY\_SW01 Cell Injection is relatively clear, demonstrating favorable therapeutic effects in preclinical animal models. Compared to existing conventional therapies, it has the advantages of "convenient treatment and sustained efficacy." It may help reduce the variety and quantity of drugs administered… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06058078?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06058078?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06058078. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06058078. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.