NCT06900764Not yet recruiting
A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus
A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 23 Mar 2025
- Start date
- 10 Oct 2025
- Primary completion date
- 15 Nov 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Lupus (SLE)
- NCT number
- NCT06900764
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 10 Oct 2025 to the primary completion date, 15 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
Other illness
- Had or has active malignancy;
- Combined with other autoimmune disease that needs treatment;
Other
- Pregnant or lactating women;
- Has other factors that deemed not suitable by investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Union Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.