Actively Recruiting
Clinical Study of Core Blood-derived Anti-CD19 IL-10/IL15 CAR-NK in the Treatment of Refractory/Relapsed Autoimmune Diseases
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-29
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of Anti-CD19 IL-10/IL15 CAR-NK cells in people with difficult-to-treat or relapsed autoimmune diseases. These diseases include systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA-associated vasculitis, Sjogren's syndrome, and antiphospholipid syndrome. This is a single-center, open-label trial designed to evaluate these cells in patients who have not responded well to standard treatments. Participants will receive conditioning treatment with Fludarabine and Cyclophosphamide before being given multiple doses of Anti-CD19 IL-10/IL15 CAR-NK cells. These cell infusions occur on Day 0, Day 3, and Day 6. The study includes a dose-escalation phase to assess safety and observe effects at different dose levels. During the trial, researchers will monitor participants for adverse events and dose-limiting toxicities within the first 28 days after infusion and over 12 months. They will also assess disease activity through specific scores and response criteria tailored to each autoimmune condition, such as SLEDAI-2K for lupus and mRSS for systemic sclerosis, over 12 to 48 weeks. Participants will be followed and evaluated regularly to track safety, treatment effects, and disease progression over time.
CONDITIONS
Brief Title
Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years old, male or female
- Hemoglobin ≥60 g/L, white blood cell count ≥2.5×10⁹/L, neutrophil count ≥1.0×10⁹/L without recent colony-stimulating factor treatment
- Liver function within limits: ALT ≤3×ULN, AST ≤3×ULN, total bilirubin ≤1.5×ULN
- Coagulation function: INR <1.5×ULN, prothrombin time <1.5×ULN
- Good cardiac function with stable hemodynamics
- Negative pregnancy test and agreement to use effective contraception for females of childbearing age
- Willing to participate voluntarily and sign informed consent
- Specific disease criteria for systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA-associated vasculitis, Sjogren's syndrome, or antiphospholipid syndrome as detailed in protocol
You will not qualify if you...
- Presence of other connective tissue diseases
- Severe involvement of heart, kidney (eGFR <15 ml/min/1.73m²), liver, lung, or blood disorders
- Active or chronic hepatitis B or C infection
- Active or latent tuberculosis
- HIV infection
- Serious active infections requiring recent hospitalization or antibiotic treatment
- Primary or secondary immunodeficiency
- IgA deficiency (<10 mg/dL) or IgG deficiency (<400 mg/dL)
- Participation in other drug trials within 3 months
- History of malignancy within 5 years except certain skin or cervical cancers
- Pregnancy, breastfeeding, or planning pregnancy without contraception
- Allergy to human or murine proteins or monoclonal antibodies
- Recent live vaccine administration within 4 weeks
- Psychiatric disorders or substance abuse affecting compliance
- Other conditions deemed unsuitable by investigators
- Additional condition-specific exclusions for systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, Sjogren's syndrome, and antiphospholipid syndrome as detailed in protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 week
Participants receive conditioning with Fludarabine and Cyclophosphamide followed by multiple doses of Anti-CD19 IL-10/IL15 CAR-NK cells infused on Day 0, 3, and 6.
3 infusion visits (in-person)
Duration - 12 months
Participants are monitored for safety and treatment effects up to 12 months after infusion.
Regular visits during follow-up period
Trial Site Locations
Total: 1 location
1
the second affiliated hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
J
Jing Xue, MD.,
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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