NCT06058078

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu Renocell Biotech Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is an exploratory study, including two stages: the dose-escalation phase (Phase I) and the dose-expansion phase (Phase II), as part of a multicenter clinical trial. The Phase I dose-escalation stage employs a dose-escalation trial design, aiming to evaluate the safety, tolerability, and preliminary efficacy of RY\_SW01 cell injection in treating patients with active lupus nephritis. The Phase II dose-expansion stage utilizes a randomized controlled trial design to further evaluate the safety and effectiveness of RY\_SW01 cell injection. The baseline treatment in this trial includes steroids in combination with immunosuppressants. Common immunosuppressants include mycophenolate mofetil, mycophenolate sodium, cyclophosphamide, azathioprine, and calcineurin inhibitors (cyclosporine or tacrolimus), which will be chosen by the researchers based on the patient's condition. During Phase II, the subject's existing baseline treatment regimen must not be increased or changed. If a subject's treatment is assessed as ineffective or intolerable and continuing the existing baseline treatment regimen will not yield better benefits, they may withdraw from the trial and then change their treatment plan or increase the dosage. Such subjects should be included in the effectiveness analysis.The trial will enroll active lupus nephritis patients aged ≥18 and ≤65 years, who must meet all inclusion criteria and none of the exclusion criteria. Approximately 69-78 subjects are planned to be enrolled to undergo the dose-escalation and dose-expansion trials with RY\_SW01 cell injection. About 9-18 evaluable subjects will be enrolled in the dose-escalation stage, and approximately 60 subjects in the dose-expansion stage.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	RY_SW01 cell injection	Injected RY\_SW01 allogonic umbilical cord-derived mesenchymal stem cells(UCMSCs)
DRUG	Basic treatment	Drugs for LN treatment

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2023-09-28
• Last updated: 2024-01-18

Locations

1 site across 1 country: China