Actively Recruiting
Anti-CD19 CAR-NK Cells in Refractory/Relapsed Systemic Lupus Erythematosus
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-05-25
10
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, open-label, single-arm trial. The aim of this study is to investigate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus.
CONDITIONS
Official Title
Anti-CD19 CAR-NK Cells in Refractory/Relapsed Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Voluntarily agree to participate and sign informed consent
- Meet the 2019 ACR/EULAR classification criteria for SLE
- Have anti-dsDNA antibodies or low C3/C4 complement levels
- SLE disease activity index (SLEDAI-2K) score of 8 or higher
- Disease not responding to routine treatment or relapsed after remission
- Blood counts: hemoglobin ≥ 80 g/L; white blood cells ≥ 3 x 10^9/L; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 30 x 10^9/L
- Normal organ function: liver enzymes ≤ 2 times upper limit; eGFR ≥ 30 ml/min/1.73m2; total bilirubin ≤ 2.0 mg/dL; left ventricular ejection fraction ≥ 50%; blood oxygen saturation >94%; clotting times within 1.5 times normal
- Females of childbearing potential must use effective contraception during the study
You will not qualify if you...
- History of severe allergy or hypersensitivity to any components of the cell product
- Pregnant or breastfeeding women
- Severe lupus nephritis with serum creatinine > 2.5 mg/dL or recent hemodialysis
- Recent severe lupus crises such as CNS lupus, severe anemia, thrombocytopenia, agranulocytosis, heart damage, pneumonia, hepatitis, or vasculitis within 8 weeks
- Other autoimmune diseases needing systemic therapy except secondary Sjogren's syndrome
- Significant CNS diseases or damage unrelated to lupus
- Active or chronic hepatitis B or C infection, untreated HIV infection
- High cytomegalovirus DNA levels
- Active or latent tuberculosis
- Uncontrollable infections needing antibiotics
- Immunodeficiency disorders
- IgA deficiency
- Uncontrolled acute or chronic diseases not related to SLE
- History of malignant tumors except certain treated cancers
- Active skin diseases interfering with SLE assessment
- Prior cell therapy or gene therapy
- Contraindications to cyclophosphamide or fludarabine
- Prior CD19-targeted therapy
- Recent live vaccine within 4 weeks
- Recent major surgery or planned surgery during trial
- B-cell targeted therapy within 4 weeks
- Plasmapheresis within 3 months
- Participation in other clinical trials within 3 months
- History of organ or bone marrow transplantation
- Any condition deemed inappropriate by investigators for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China, China, 310016
Actively Recruiting
Research Team
H
Huaxiang Wu, PhD
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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