Overview
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
Status:
Recruiting
Recruiting
Trial end date:
2028-12-31
2028-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jiangsu Renocell Biotech CompanyCollaborator:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolTreatments:
Immunosuppressive Agents
Criteria
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.