RY_SW01 Cell Injection Therapy in Active Lupus Nephritis

NCT06058078 | Recruiting Phase 2

• 1 other identifier: RYSW202201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lupus Nephritis

Keywords

RY_SW01 cell injection

Outcome Measures

Primary Outcomes (3)

• Frequency of Adverse Events

  Within 24 week

• Proportion of patients achieving a primary renal efficacy response (PERR)

  24week

• Proportion of patients achieving a complete response (CR)

  24week

Secondary Outcomes (13)

• Frequency of adverse events and severe adverse events

  within 24 weeks

• Proportion of patients achieving primary renal efficacy response (PERR)

  12 week

• Proportion of patients achieving primary renalcomplete response (CR)

  12 week

• Changes in urine protein/creatinine ratio (UPCR) relative to baseline

  12 week

• Changes in eGFR(estimated glomerular filtration rate)relative to baseline

  12 week

Study Arms (3)

RY_SW01 group 1 does 1 RY_SW01 cell injection

EXPERIMENTAL

Receive the best basic treatment and one million cells per kilogram of body weight

Drug: RY_SW01 cell injection; Drug: Basic treatment

RY_SW01 group 2 does 2 RY_SW01 cell injection

EXPERIMENTAL

Receive the best basic treatment and two million cells per kilogram of body weight

Drug: RY_SW01 cell injection; Drug: Basic treatment

control group

OTHER

Receive the best basic treatment

Drug: Basic treatment

Interventions

RY_SW01 cell injection DRUG

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

Also known as: UC-MSC treatment

RY_SW01 group 1 does 1 RY_SW01 cell injection; RY_SW01 group 2 does 2 RY_SW01 cell injection

Basic treatment DRUG

Drugs for LN treatment

Also known as: Immunosuppressive drugs

RY_SW01 group 1 does 1 RY_SW01 cell injection; RY_SW01 group 2 does 2 RY_SW01 cell injection; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign an informed consent form.
• Male or female aged ≥18 and ≤65 years.
• 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.
• 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.
• 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).
• Laboratory examination showing a urinary protein-to-creatinine ratio (UPCR) \> 1000 mg/g or 100 mg/mmol or \> 1.0.
• 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.

You may not qualify if:

• 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.
• Severe kidney dysfunction with eGFR \< 30 mL/min/1.73m² or serum creatinine \> 265.2 µmol/L.
• Kidney biopsy pathology indicating ≥50% glomerulosclerosis.
• 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).
• 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).
• Patients with a history of IgA deficiency (IgA \< 10 mg/dL).
• 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.
• Received live vaccines or attenuated live vaccines within the previous 12 weeks or expect to receive/require live vaccines during the trial.
• Underwent plasmapheresis or immunoadsorption therapy within the previous 24 weeks or received intravenous immunoglobulin (IVIG) therapy within the previous 4 weeks.

Sponsors & Collaborators

• Jiangsu Renocell Biotech Company: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

the Affiliated Drum Tower Hospital, Medical School, Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sun Lingyun

  the Affiliated Drum Tower Hospital, Medical School, Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Wei

CONTACT

15852926678; weining@rybiotech.cn

Jing Wang

CONTACT

025-86162919; wangjing@rybiotech.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: August 17, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)