Lupus NephritisPhase 2NCT06058078
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
A Phase 2 study testing RY_SW01 cell injection and Basic treatment in people with Lupus Nephritis, run by Jiangsu Renocell Biotech Company at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- RY_SW01 cell injection and Basic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2023to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 30Show fewer
- 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.
- Used other investigational drugs within the previous 12 weeks.
- 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.
- 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).
- 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.
- 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.
- Pregnant or lactating women.
- 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.
- Participants judged by the investigator as not suitable for participation in this trial will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Affiliated Drum Tower Hospital, Medical School, Nanjing University
Nanjing, Jiangsu, 210008
Lingyun Sun
About this study
Official title: A Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of RY_SW01cell Injection Therapy in Active Lupus Nephritis
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.
Read the 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
- Being tested
- RY_SW01 cell injection, Basic treatment
- Keywords
- RY_SW01 cell injection
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RY_SW01 cell injectionDrug
Also called UC-MSC treatment
Injected RY_SW01 allogonic umbilical cord-derived mesenchymal stem cells(UCMSCs)
Basic treatmentDrug
Also called Immunosuppressive drugs
Drugs for LN treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: RY_SW01 cell injection; Drug: Basic treatment |
| control group | Other | Receive the best basic treatment Receives: Drug: Basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Measured: Within 24 week
Proportion of patients achieving a primary renal efficacy response (PERR)
Measured: 24week
Proportion of patients achieving a complete response (CR)
Measured: 24week
Secondary outcomes (13)
Frequency of adverse events and severe adverse events
Measured: within 24 weeks
Proportion of patients achieving primary renal efficacy response (PERR)
Measured: 12 week
Proportion of patients achieving primary renalcomplete response (CR)
Measured: 12 week
Changes in urine protein/creatinine ratio (UPCR) relative to baseline
Measured: 12 week
Changes in eGFR(estimated glomerular filtration rate)relative to baseline
Measured: 12 week
Changes in SLEDAI-2000(The Systemic Lupus Erythematosus Disease Activity Index 2000) ralative to baseline
Measured: 24 week
Changes in PGA(Physician Global Assessment) ralative to baseline
Measured: 24 week
Changes in SF-36 (Short-form 36 Questionnaire) ralative to baseline
Measured: 24 week
The proportion of patients reduced dosage of basic treatment drugs
Measured: 24week
Serum biomarkers of antibody
ANA,nti-dsDNA antibody
Measured: Within 24 weeks
the proportion of Treg cell subset
Measured: 24 week
Serum biomarkers
C3,C4
Measured: Within 24 weeks
Serum biomarkers of cytokins
TGF-β，IFN-γ，IL-6,IgG,CXCL10
Measured: Within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start17 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Renocell Biotech Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sun Lingyun, MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Sun Lingyun, Principal investigator, the Affiliated Drum Tower Hospital, Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058078
- Sponsor's protocol ID
- RYSW202201
- Status last verified
- Jan 2024
- First submitted
- 21 Sep 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of RY_SW01cell Injection Therapy in Active Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06058078
- Acronym / sponsor ID
- RYSW202201
- Conditions
- Lupus Nephritis
- Keywords
- RY_SW01 cell injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Renocell Biotech CompanyIndustry (pharma, biotech, devices)
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RY_SW01 group 1 does 1 RY_SW01 cell injection | Experimental | Drug: RY_SW01 cell injection, Drug: Basic treatmentReceive the best basic treatment and one million cells per kilogram of body weight |
| RY_SW01 group 2 does 2 RY_SW01 cell injection | Experimental | Drug: RY_SW01 cell injection, Drug: Basic treatmentReceive the best basic treatment and two million cells per kilogram of body weight |
| control group | Other | Drug: Basic treatmentReceive the best basic treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (30 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RY_SW01 cell injectionAlso: UC-MSC treatmentInjected RY_SW01 allogonic umbilical cord-derived mesenchymal stem cells(UCMSCs) | Drug | RY_SW01 group 1 does 1 RY_SW01 cell injection, RY_SW01 group 2 does 2 RY_SW01 cell injection |
| Basic treatmentAlso: Immunosuppressive drugsDrugs for LN treatment | Drug | RY_SW01 group 1 does 1 RY_SW01 cell injection, RY_SW01 group 2 does 2 RY_SW01 cell injection, control group |
Primary outcome
Frequency of Adverse Events
Time frame: Within 24 week
Proportion of patients achieving a primary renal efficacy response (PERR)
Time frame: 24week
Proportion of patients achieving a complete response (CR)
Time frame: 24week
13 secondary outcomes
Frequency of adverse events and severe adverse events
Time frame: within 24 weeks
Proportion of patients achieving primary renal efficacy response (PERR)
Time frame: 12 week
Proportion of patients achieving primary renalcomplete response (CR)
Time frame: 12 week
Changes in urine protein/creatinine ratio (UPCR) relative to baseline
Time frame: 12 week
Changes in eGFR(estimated glomerular filtration rate)relative to baseline
Time frame: 12 week
Changes in SLEDAI-2000(The Systemic Lupus Erythematosus Disease Activity Index 2000) ralative to baseline
Time frame: 24 week
Changes in PGA(Physician Global Assessment) ralative to baseline
Time frame: 24 week
Changes in SF-36 (Short-form 36 Questionnaire) ralative to baseline
Time frame: 24 week
The proportion of patients reduced dosage of basic treatment drugs
Time frame: 24week
Serum biomarkers of antibody
Time frame: Within 24 weeks
the proportion of Treg cell subset
Time frame: 24 week
Serum biomarkers
Time frame: Within 24 weeks
Serum biomarkers of cytokins
Time frame: Within 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Lupus Nephritis
RecruitingPhase 2
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Lupus Nephritis
RecruitingObservational study
Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus
SLE - Systemic Lupus Erythematosus
RecruitingObservational study
Study of Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Not yet recruitingPhase 1/2
CD19-Directed CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Active, not recruitingPhase 3
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
Lupus Nephritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sun Lingyun principal investigator
the Affiliated Drum Tower Hospital, Medical School, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RY_SW01 cell injection and Basic treatment in people with Lupus Nephritis, run by Jiangsu Renocell Biotech Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Wei (15852926678, weining@rybiotech.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: Within 24 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.