Actively Recruiting
NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus Nephritis
Led by Guangdong Provincial People's Hospital · Updated on 2025-05-29
18
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China.
CONDITIONS
Official Title
NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, male or female.
- Diagnosis of systemic lupus erythematosus (SLE) according to 2019 EULAR/ACR criteria.
- For lupus nephritis subgroup: active type III or IV lupus nephritis confirmed by kidney biopsy with activity index 2 and moderate or less chronicity index.
- Urine protein/creatinine ratio 2 1.0 g/g or 24-hour urine protein 2 1.0 g/day.
- Positive antinuclear antibody (ANA) or anti-dsDNA or anti-Smith antibody.
- SLEDAI-2000 disease activity score 2 8.
- Prior treatment with glucocorticoids combined with immunosuppressants and/or biologics for at least 3 months with stable doses for more than 2 weeks but disease still active.
- Adequate blood counts and organ function: leukocytes 2 x 10 9/L, lymphocytes 2 0.5 x 10 9/L, ALT and AST 3 times upper limit of normal, total bilirubin 2 1.5 times upper limit (except Gilbert's syndrome up to 3.0 times), eGFR 2 30 ml/min/1.73 m2, oxygen saturation 2 92% without oxygen, no significant pleural effusion, left ventricular ejection fraction 2 45%, normal ECG.
- INR or prothrombin time 2 1.5 times upper limit if not on anticoagulation.
- At least 2 weeks since last hematopoietic growth factor therapy and appropriate intervals since blood transfusions.
- Negative pregnancy test for females of childbearing potential; use of effective contraception by females and males during study and 1 year after.
- Willingness to participate and sign informed consent.
You will not qualify if you...
- Requirement for dialysis at screening or expected need during study.
- Previous or planned solid organ or hematopoietic cell transplant during study.
- Congenital or acquired immunodeficiency causing serious infection or ongoing immunoglobulin therapy.
- Active mixed connective tissue disease or systemic sclerosis overlapping syndrome within 12 months prior or during screening that may affect study outcomes.
- Receipt of B-cell depletion therapy within 6 months or biologic therapy within 1 month before screening.
- Known allergy or severe reaction to study drugs or components.
- Significant central nervous system disease not related to lupus within 3 months before first dose.
- Unstable heart conditions including recent heart attack, uncontrolled arrhythmias, heart failure grade 3 or higher, prolonged QT interval, uncontrolled high blood pressure.
- Active bleeding or infection, except mild fungal nail infections.
- Active infection treated with IV antibiotics within 14 days before screening.
- Positive HIV or syphilis antibodies.
- Positive hepatitis B surface antigen; hepatitis B core antibody positive but DNA negative allowed with monitoring.
- Positive hepatitis C antibody but no active virus allowed with monitoring.
- Risk or evidence of active or latent tuberculosis.
- Malignant tumor within 5 years except certain cured cancers without recurrence.
- Prior cell therapy such as CAR-T or CAR-NK.
- Pregnant or breastfeeding women or those not using contraception or planning to donate eggs/sperm.
- Any life-threatening disease or medical condition that may affect safety or compliance according to investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdomg, China, 510080
Actively Recruiting
Research Team
X
Xueqing Yu, Ph.D
CONTACT
L
Li Fan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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