Actively Recruiting
UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Systemic Lupus Erythematosus
Led by Zhejiang University · Updated on 2025-05-01
18
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
S
Shanghai Xiniao Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Systemic lupus erythematosus. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
CONDITIONS
Official Title
UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with systemic lupus erythematosus based on 2019 EULAR/ACR criteria
- Lupus nephritis confirmed by renal biopsy within 6 months showing active nephritis type III, IV, or V
- Refractory or relapsed disease after at least 6 months of conventional treatment including glucocorticoids and immunomodulatory drugs
- SLEDAI-2000 score of 8 or higher
- NIH activity index of lupus nephritis greater than 2 with increased chronicity index
- Urinary protein: creatinine ratio greater than 1.0 g/g or 24-hour urinary protein greater than 0.5 g
- Positive for B cell CD19 or BCMA by flow cytometry in peripheral blood
- Adequate bone marrow function with neutrophil count ≥ 0.5 × 10^9/L, hemoglobin ≥ 60 g/L, platelets ≥ 20 × 10^9/L
- Liver function with ALT and AST ≤ 3 times upper limit of normal, total bilirubin ≤ 2.0 times upper limit (or ≤ 3.0 times for Gilbert syndrome)
- Renal function with creatinine clearance ≥ 30 ml/min
- ECOG performance status 0-1
- Use of approved contraception or abstinence during treatment and for 6 months after
- Negative pregnancy test within 7 days before enrollment and not breastfeeding
- Willingness to participate, provide informed consent, and comply with follow-up
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- Uncontrolled or active fungal, bacterial, viral, or other infections
- Central nervous system diseases caused by autoimmune or non-autoimmune conditions
- Insufficient cardiac function
- Congenital immunoglobulin deficiencies
- History of cancer within the past 5 years
- End-stage renal failure
- Positive for hepatitis B surface antigen or core antibody with high HBV DNA levels
- Positive for hepatitis C virus antibody and RNA
- Positive for HIV infection
- Psychiatric disorders or severe cognitive impairments
- Participation in other clinical trials within 3 months prior to enrollment
- Use of immunosuppressive agents or biologics with effects on the disease within five half-lives before enrollment
- Pregnancy or planning to conceive
- Investigator judgment of other reasons making the participant unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
H
He Huang
CONTACT
Y
Yongxian Hu
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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