lupus nephritis
Conditions
Interventions
Treatment group:Zuberitamab
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed informed consent; 2. Aged 18-75 years old; 3. Patients diagnosed as systemic lupus erythematosus and diagnosed as lupus nephritis by renal biopsy or persistent positive urine test; 4. Female subjects of childbearing potential had negative pregnancy test and agreed to use effective contraceptive measures during the trial and within 18 months after the last dose; 5. Male subjects agreed to use effective contraceptive measures during the trial and within 12 months after the last dose, and agreed to avoid sperm donation during this period.
Exclusion criteria
Exclusion criteria: 1. Patients who lack peripheral venous access; 2. Chronic diseases that require oral or systemic use of steroids (within one year before screening), excluding SLE (e.g. asthma, Crohn's disease); 3. In any SLE or LN-unrelated organ system, there are significant or uncontrolled medical diseases that researchers consider unsuitable for participation in this study; 4. Patients who are pregnant or lactating; 5. Severe allergy or have a history of allergic reaction to monoclonal antibodies, or be allergic to any component of Zuberitamab; 6. Patients infected with HIV; any type of active infection (excluding nail bed fungal infection)or any major infection that requires hospitalization or intravenous anti-infective drug treatment within 8 weeks, or had oral anti-infective drugs within the first 2 weeks before screening; or having a history of severe recurrent or chronic infection; 7. Hepatitis B surface antigen (HbSAg) or hepatitis C serological positive. Patients with HBsAg negative and hepatitis B core antibody positive and undetected DNA are allowed to enter this study, but regular monitoring of hepatitis B virus DNA is required; 8. History of cancer, including solid tumors, blood malignant tumors and cancer in situ (except for skin basal cell carcinoma that has been treated or removed); 9. Have a history of alcoholism or drug abuse, or a history of alcohol or drug abuse within 52 weeks before screening; 10. Surgeries that require hospitalization within the first 4 weeks before screening (excluding diagnostic surgeries); 11. Have been treated in any of the following cases: received anti-CD20 targeted treatment within 12 months before screeningreceived B cell targeted treatment (except for anti-CD20 treatment) within 6 months before screening;received B cell targeted treatment (except for anti-CD20 treatment) within 6 months before screening; received the experimental drug within 28 days before screening or within 5 half-lifes (whichever is longer) 12. had live vaccine within 28 days before screening(it is recommended that patients get vaccine for pneumococcal, herpes zoster, and seasonal influenza in advance);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of CRR patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of PRR patients;Response time of CRR + PRR;The proportion of LLDAS patients;Changes of active biomarkers of LN disease relative to baseline;The proportion of patients with UPCR<0.8;Analysis of peripheral blood lymphocytes and lymphatic factors; | — |
Countries
China
Contacts
Public ContactLi Sun
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed