Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06058078
Study type Interventional
Source Jiangsu Renocell Biotech Company
Contact Ning Wei
Phone 15852926678
Email weining@rybiotech.cn
Status Recruiting
Phase Phase 2
Start date August 17, 2023
Completion date December 31, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT02936375 - The Iguratimod Effect on Lupus Nephritis (IGeLU) Phase 2
Completed NCT03597464 - Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin Phase 3
Recruiting NCT01226147 - Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis Phase 2
Completed NCT01206569 - Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis Phase 4
Active, not recruiting NCT00569101 - A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis Phase 2
Terminated NCT00368264 - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) Phase 2/Phase 3
Completed NCT00371319 - Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis Phase 4
Completed NCT00298506 - Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V) N/A
Completed NCT00094380 - Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) Phase 1/Phase 2
Terminated NCT04376827 - A Study of Guselkumab in Participants With Active Lupus Nephritis Phase 2
Completed NCT03610516 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis. Phase 2
Recruiting NCT03526042 - Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis N/A
Withdrawn NCT03859570 - Pentoxifylline in Lupus Nephritis Phase 4
Completed NCT03664908 - Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)? N/A
Completed NCT01085097 - A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis Phase 2
Active, not recruiting NCT05704088 - SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients Phase 4
Not yet recruiting NCT06429800 - A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis Phase 1
Recruiting NCT02226341 - ACTHar in the Treatment of Lupus Nephritis Phase 4
Recruiting NCT02453997 - Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis N/A
Completed NCT01470183 - Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients N/A