Active lupus nephritis
Conditions
Interventions
Dose escalation phase (Phase I) : middle dose group:RY_SW01 cell injection 2.0×10^6 cells /kg treatment
Dose escalation phase (Phase I) : high dose group:RY_SW01 cell injection 3.0×10^6 cells /kg treatment
Dose expansion phase (Phase II) : Contrast group:basic treatment
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. voluntarily sign an informed consent form; 2. men or women >=18 and = 6; 4. prior induction therapy (two or more hormones in combination with immunosuppressants, biologics, etc.) that, in the judgment of the investigator, was intolerant or ineffective; treatment ineffectiveness is defined in accordance with the recommended criteria of the Guidelines for the Treatment of Lupus Nephritis, developed by the European League Against Rheumatism, the European Renal Association, and the European Dialysis and Transplantation Association, 2019: Within 3 months of the start of induced remission therapy for lupus nephritis Urine protein reduction of less than 25% of pre-treatment or 50% of pre-treatment at 6 months or random urine UPCR >500 mg/g or 50 mg/mmol or >0.5 at 12 months. 5. patients with renal biopsy results confirming a diagnosis of type III/IV lupus nephritis (type III(A), III(A+C), IV(A), or IV(A+C)) according to the ISN/RPS staging criteria, either in combination with type V or with type V alone (with active and chronic indices); 6. a laboratory urine protein/creatinine ratio (UPCR) of >1000 mg/g or 100 mg/mmol or >1.0; 7. not planning to have children during the trial period and for at least 1 year after administration of the injectable drug, and voluntarily using effective contraception with their partner (see Appendix 1) and not planning to donate sperm or eggs.
Exclusion criteria
Exclusion criteria: 1. with severe hepatic impairment with any of the following abnormalities: total bilirubin > 2 times ULN; ALT or AST > 2 times ULN. 2. with severe renal impairment with eGFR 265.2µmol/L; 2. with severe renal impairment with eGFR 265.2 µmol/L; 3. renal biopsy pathology suggestive of >=50% glomerulosclerosis; 4. accompanied by hematologic abnormalities with any of the following: white blood cell count =160/100 mmHg); (2) Patients with uncorrected heart failure or severe cardiac insufficiency (NYHA class >=III); (3) Patients with a history of myocardial infarction within 6 months prior to screening or who meet the diagnostic criteria for acute myocardial infarction as determined by the investigator at the time of screening; (3) Patients with a history of myocardial infarction within 6 months prior to screening or who meet the diagnostic criteria for acute myocardial infarction as determined by the investigator at screening; (4) Patients with a history of acute stroke within 6 months prior to screening or at risk of acute cerebrovascular accident as determined by the investigator at the time of screening; (4) Patients with a history of acute stroke within 6 months prior to screening or at risk of acute cerebrovascular accident as determined by the investigator at screening; (5) Patients with a co-morbid history of severe pulmonary hypertension; (6) Patients with severe cardiac arrhythmias (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.); 6. patients with a history of IgA deficiency (IgA = 500 IU/ml); have a severe A history of active or recurrent bacterial, viral, fungal, parasitic, or other infections during the screening period; 12. a history of malignancy within 5 years, including solid tumors, hematologic malignancies, or carcinoma in situ (except resected or cured basal cell carcinoma of the skin); 13. have had any major surgery within 12 weeks prior to screening, or have required major surgery during the trial t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Incidence of dose-limiting toxicity events;Phase II: Incidence of adverse events;Phase II: Proportion of primary efficacy renal response (PERR).;Proportion of nephritis complete remission (CR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Long-term safety;Phase I: Incidence of adverse events;Phase I: Proportion of primary efficacy renal response (PERR);Stage I: Proportion of nephritis in complete remission (CR).;Stage I: Change from baseline in urine protein/creatinine ratio (UPCR), eGFR;Phase I: SLEDAI-2000 score, PGA score, SF-36 scale score and other indicators and their relative baseline changes;Phase I: Proportion of reduction in the amount of underlying treatment medications;Phase I: Changes in serum biomarkers;Phase II: Incidence of adverse events and serious adverse events;Stage II: Change from baseline in urine protein/creatinine ratio (UPCR), eGFR;Phase II: Indicators such as SLEDAI-2000 score, PGA score, SF-36 scale score, etc., and their changes from baseline;;Phase II: Proportion of reductions in the amount of primary treatment medications;Phase II: Changes in serum biomarkers; | — |
Countries
China
Contacts
Public ContactSun Lingyun
Nanjing Drum Tower Hospital
Outcome results
None listed