Actively Recruiting
CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-03-26
20
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE).
CONDITIONS
Official Title
CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or legal guardians understand and voluntarily sign informed consent and can complete all study procedures with good compliance
- Age between 18 and 70 years, any gender
- Diagnosed with systemic lupus erythematosus (SLE) as defined by 2019 EULAR/ACR criteria at least 24 weeks before screening
- Refractory or moderate-to-severe SLE defined by SELENA-SLEDAI score > 6, PGA ≥ 1, BILAG-2004 organ system scores of ≥1 A or 2 B, and lack of efficacy after at least 12 weeks of standard SLE treatment
- Agree to use effective contraception during the study and for 3 months after last follow-up visit if fertile
You will not qualify if you...
- Active severe lupus nephritis within 8 weeks before screening requiring prohibited medications, hemodialysis, or high-dose prednisone (≥100 mg/day) for ≥14 days
- Suicide attempt or suicidal thoughts within 1 year before screening
- Central nervous system diseases or changes related to SLE or non-SLE within 8 weeks before screening
- Diagnosis of non-SLE inflammatory joint or skin diseases
- History of vital organ or hematopoietic stem cell/bone marrow transplantation
- History of lymphoproliferative diseases
- Malignancy within 5 years before screening
- Plasma exchange, plasma separation, hemodialysis, or intravenous immunoglobulin within 14 days before screening
- Other autoimmune diseases requiring systemic therapy
- Positive hepatitis B surface antigen or core antibody with high HBV DNA, positive hepatitis C, HIV, or syphilis
- Active or latent tuberculosis at screening
- Abnormal major organ function at screening
- Unstable or uncontrolled illnesses not related to SLE
- Severe lupus lung or cardiac damage at screening
- Uncontrolled infections requiring antibiotics at screening
- Live or attenuated vaccine within 4 weeks before screening or planned during study
- Glucocorticoid injections or systemic use within 4 weeks before screening
- Use of Janus kinase (JAK) or Bruton tyrosine kinase (BTK) inhibitors within 12 weeks before screening
- Previous B-cell targeted therapy or biologic agents other than B-cell targeted therapy within 5 half-lives before screening
- Prior CAR-T or genetically modified T cell therapy
- Corticosteroid use within 7 days before leukapheresis or 72 hours before infusion
- Blood donation ≥400 mL or significant blood loss within 4 weeks before screening, blood transfusion within 8 weeks, or planned donation during study
- Grade 2 or higher bleeding history within 4 weeks before screening or need for long-term anticoagulants
- Major surgery within 12 weeks before screening or planned during study
- Drug abuse within 12 weeks before screening
- Female pregnancy, lactation, or intent to conceive within 2 years after infusion; male partners' intent to conceive within 2 years after infusion
- History of significant drug allergy or intolerance
- Participation in other clinical trials within 3 months before screening or current participation (except non-drug studies)
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital Tongji Medical College HUAZHONG University of Science and Technology
Wuhan, China
Actively Recruiting
Research Team
Q
Qiubai Li, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here