Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058078
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-09-21
Brief Title:
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
Sponsor:
Jiangsu Renocell Biotech Company
Organization:
Jiangsu Renocell Biotech Company
Study Overview
Official Title:
A Multicenter Phase III Clinical Trial to Evaluate the Safety Tolerability and Efficacy of RY_SW01cell Injection Therapy in Active Lupus Nephritis
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RY_SW01 Cell Injections 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 patients condition During Phase II the subjects existing baseline treatment regimen must not be increased or changed If a subjects 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 analysisThe 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
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 patients condition During Phase II the subjects existing baseline treatment regimen must not be increased or changed If a subjects 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 analysisThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None