Actively Recruiting
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2026-03-24
36
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
T
The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.
CONDITIONS
Official Title
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older, any gender
- Patient or legal guardian agrees to participate and signs informed consent
- Peripheral blood B cells expressing CD19 with a count greater than 5 cells/uL
- If previously treated with B cell therapy, B cell counts returned to normal or above pre-treatment level
- Normal cardiac structure and left ventricular ejection fraction of at least 55% on echocardiography; no significant abnormalities on electrocardiogram
- Liver function with AST and ALT less than or equal to 3 times the upper limit of normal; total bilirubin less than or equal to 2 times the upper limit of normal
- Renal function with estimated glomerular filtration rate of at least 30 mL/min/1.73m2 (exceptions possible with investigator approval)
- No severe pulmonary lesions and blood oxygen saturation of at least 92%
- Female participants of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the trial and for 1 year after infusion
- Diagnosed with specific refractory pediatric rheumatic diseases as per detailed disease-specific criteria including polyarticular juvenile idiopathic arthritis, Sjögren's syndrome, juvenile dermatomyositis, systemic sclerosis, systemic lupus erythematosus, or mixed connective tissue disease
- Active disease despite standard treatments and meeting disease activity score thresholds
- No occurrence of macrophage activation syndrome within 1 month prior to screening
You will not qualify if you...
- History or current diagnosis of malignancy except for certain treated skin or cervical cancers
- Allergy or intolerance to CAR-NK cells or study drugs including fludarabine, cyclophosphamide, or tocilizumab
- Severe active infections or uncontrolled systemic fungal infections requiring intravenous antimicrobial therapy
- Severe cardiac insufficiency (New York Heart Association Class III or IV), congenital heart disease, recent myocardial infarction, severe arrhythmias, or unstable vital signs needing vasopressors
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus infections
- History of severe herpes infections or recent herpes/varicella-zoster virus infections
- Active or history of tuberculosis without confirmed negative screening test
- Severe interstitial lung disease or pulmonary arterial hypertension as defined by specific lung function and clinical criteria
- History of epilepsy or other active central nervous system diseases
- Acquired or congenital immunodeficiency diseases
- Significant cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, or renal diseases precluding treatment
- Recent organ or stem cell transplant or acute graft-versus-host disease
- Recent live vaccinations or certain immunosuppressive treatments within specified time frames
- Recent participation in another clinical trial within 3 months
- Any condition judged by the investigator to increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
M
Meiping Lu, Prof.
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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