Actively Recruiting
Study of Ultra-Fast BCMA/CD70 CAR-T Therapy for Refractory SLE
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2026-02-03
18
Participants Needed
1
Research Sites
131 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 BCMA/CD70-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
CONDITIONS
Official Title
Study of Ultra-Fast BCMA/CD70 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 2019 EULAR/ACR classification criteria
- Moderate to severe disease activity despite at least 3 months of high dose glucocorticoids, hydroxychloroquine, and at least 2 DMARDs or intolerance to standard treatments
- SLEDAI-2K score of 8 points or higher
- Eligible for leukapheresis or intravenous blood collection without contraindications
- Negative pregnancy test for females of childbearing age and agreement to use effective contraception for one year after CAR-T infusion
- Signed informed consent agreeing to participate and understanding the study purpose and procedures
You will not qualify if you...
- CNS neurolupus requiring intervention within 30 days
- History of congenital heart disease, recent acute myocardial infarction (within 6 months), severe arrhythmias, NYHA class IV heart failure, moderate to massive pericardial effusion, serious myocarditis, or unstable vital signs requiring hypertensive drugs
- Renal function with eGFR less than 30 mL/min/1.73m2 or need for renal replacement therapy
- Liver function with AST and ALT over 3 times the upper limit of normal or total bilirubin over 2 times the upper limit of normal
- Lung function with oxygen saturation below 92% without oxygen support
- Uncontrolled or active infection needing systemic treatment within 3 months
- Hematopoietic stem cell transplantation within 3 months or grade 2 or higher graft versus host disease within 2 weeks
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with viral loads above normal ranges
- Active pulmonary tuberculosis at screening
- Received live vaccine within 4 weeks
- Positive pregnancy test
- Malignant tumors except certain treated and inactive cancers
- Participation in another clinical study 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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