Status:
NOT_YET_RECRUITING
A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06900764
Start Date
October 10 2025
End Date
December 20 2027
Last Update
July 17 2025
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China, 430000