Actively Recruiting
Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus Erythematosus
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2024-11-15
18
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated trial to evaluate the safety and efficacy of CD19 Universal CAR-T cells in the treatment of refractory systemic lupus erythematosus.
CONDITIONS
Official Title
Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older
- Diagnosed with SLE according to 2019 EULAR/ACR criteria and still have moderate to severe disease activity despite treatment with high dose glucocorticoids and at least two other specified immunosuppressive drugs, or intolerant to standard treatments
- SLEDAI 2K score of 8 points or higher
- Normal important organ functions including cardiac function (LVEF 65%, normal ECG), kidney function (eGFR 630 ml/min/1.73m2), liver function (AST and ALT 63.0 ULN, TBIL 62.0x ULN), and lung function (no serious lesions, SpO2 62 92%)
- Eligible for leukapheresis or intravenous blood collection with no contraindications
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception for one year after CAR-T infusion
- Informed consent signed by participant or guardian
You will not qualify if you...
- Previous CAR T-cell therapy
- Central nervous system disease requiring intervention within 60 days
- Active tuberculosis at screening
- History of congenital heart disease, recent myocardial infarction, severe arrhythmias, significant pericardial effusion, serious myocarditis, or unstable vital signs needing hypertensive drugs
- Other diseases requiring long-term use of glucocorticoids or high-dose immunosuppressants
- Uncontrollable or active infection needing systemic treatment within one week before screening
- History of organ or stem cell transplantation or Grade 2 or higher GVHD within two weeks before screening
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus with viral loads above normal ranges
- Receipt of live vaccine within four weeks before screening
- Positive pregnancy test
- Past or current malignancy
- Participation in another clinical study within three months prior to enrollment
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
J
Jianhua Mao, Prof
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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