Actively Recruiting
Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2026-01-12
18
Participants Needed
1
Research Sites
134 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 18 years or older
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria
- Moderate to severe disease activity despite high-dose glucocorticoids (prednisone 61mg/kg/day or equivalent) and/or hydroxychloroquine
- Treated with at least two disease-modifying antirheumatic drugs (DMARDs) or intolerant to standard treatments
- SLEDAI-2K score of 8 points or higher
- Eligible for leukapheresis or intravenous blood collection with no contraindications
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception for one year after CAR-T infusion
- Participant or guardian willing to provide informed consent and understand the study procedures
You will not qualify if you...
- Central nervous system lupus requiring intervention within 30 days
- History of congenital heart disease, recent acute myocardial infarction (within 6 months), severe arrhythmias, or class IV heart failure
- Moderate to severe pericardial effusion, serious myocarditis, or unstable vital signs requiring hypertension drugs
- Severe organ dysfunction: renal (eGFR <30 mL/min/1.73m2 or renal replacement therapy), liver (AST/ALT >3 times upper limit or bilirubin >2 times upper limit), or lung (SpO2 <92% without oxygen)
- Active or uncontrolled infection requiring systemic treatment within 3 months
- Hematopoietic stem cell transplantation within 3 months or grade 2 or higher GVHD within 2 weeks
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with viral loads above normal
- Active pulmonary tuberculosis
- Live vaccine received within 4 weeks prior to screening
- Positive pregnancy test
- Malignant tumors except certain treated cancers with no active lesions
- 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
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
L
Lingyun Sun
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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