A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called CAR-T cell therapy for people with Systemic Lupus Erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues. The goal of the study is to see if this therapy is safe and effective for patients with SLE who are still experiencing symptoms despite being on standard treatments for at least six months. The trial is set to begin soon, and they are looking for participants aged 18 to 65 who have a confirmed diagnosis of SLE and meet certain health criteria.

Eligible participants will need to have specific test results showing active disease and must not have received certain previous treatments, like other gene therapies. If you join the study, you'll be monitored closely to ensure your safety throughout the process. This is an important opportunity to help researchers learn more about how CAR-T therapy might help people with SLE, and your participation could contribute to advancements in treatment for this challenging condition.

Gender

ALL

Eligibility criteria

• 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.