Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Not applicable
Started
2025-10-10
Last updated
2025-07-17
Condition(s) studied
Systemic Lupus Erythematosus (SLE)
Investigational drug(s) / intervention(s)
CAR-T cell
CAR-T cell: CAR-T cell
Study summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female, between 18 and 65 years old;
* Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
* Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
* SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
* Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
* Good organ functions;
* Voluntary participates this trial and can comprehend and sign ICF.
Exclusion Criteria:
* Had or has active malignancy;
* Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
* Combined with other autoimmune disease that needs treatment;
* Pregnant or lactating women;
* Has other factors that deemed not suitable by investigator.
Primary outcome measure(s)
Dose Limiting Toxicity — 0~28 day after treatment
Frequency of AEs, SAEs — 0 day to 24 months after treatment
Trial sites (1)
Facility
City
Region
Status
Wuhan Union Hospital
Wuhan
Hubei
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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