Actively Recruiting
Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-11-18
18
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
CONDITIONS
Official Title
Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older, no gender limitation
- Diagnosed with SLE according to 2019 EULAR/ACR criteria
- Moderate to severe disease activity despite at least 3 months of high-dose glucocorticoids, hydroxychloroquine, and at least 2 disease-modifying anti-rheumatic drugs (DMARDs)
- SLEDAI-2K score of 8 points or higher
- Normal important organ functions including heart (LVEF 6%), kidney (eGFR 30 mL/min/1.73m2), liver (AST and ALT 3 times upper limit of normal, TBIL 2 times ULN), and lung (SpO2 9%)
- Eligible for leukapheresis or intravenous blood collection
- Negative pregnancy test for females of childbearing age and agreement to use effective contraception for one year after treatment
- Willing to provide informed consent and participate in the study
You will not qualify if you...
- Central nervous system lupus requiring intervention within 60 days
- Severe acute nephritis requiring recent or planned high-dose glucocorticoids or immunosuppressants
- History of congenital heart disease, severe arrhythmias, or unstable vital signs needing medication
- Uncontrolled or active infections needing systemic treatment within 3 months
- Organ or stem cell transplantation within 3 months or recent graft-versus-host disease
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral loads
- Macrophage activation syndrome within 1 month unless cleared by researchers
- Previous CAR-T therapy unless cleared by researchers
- Active pulmonary tuberculosis at screening
- Receipt of live vaccine within 4 weeks prior to screening
- Positive pregnancy test
- Previous or current cancer
- Participation in another clinical trial within 3 months
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
J
Jianhua Mao, MD
CONTACT
X
Xue He
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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