Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
SLE, Systemic Lupus Erythematosus
Brief summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
Interventions
DRUGCAR-T cell
CAR-T cell
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity | 0~28 day after treatment |
| Frequency of AEs, SAEs | 0 day to 24 months after treatment |
Countries
China
Contacts
Primary ContactQiubai Li, MD/PhD
Outcome results
None listed