Actively Recruiting
A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-01-08
15
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
G
Guangzhou Bio-gene Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to explore the safety and efficacy of CD19 CAR-T in active systemic lupus erythematosus.
CONDITIONS
Official Title
A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or their guardians understand and voluntarily sign the informed consent form and can complete all study procedures with good compliance
- Age between 18 and 70 years, any gender
- Body weight of at least 40 kg
- Diagnosed with systemic lupus erythematosus (SLE) according to the American College of Rheumatology 1997 criteria at least 24 weeks before consent
- Active SLE with SELENA-SLEDAI score of 6 or higher and Physician Global Assessment score of 1 or higher at screening
- Received at least 8 weeks of standard treatment for SLE prior to screening
- Female participants must have a negative pregnancy test and agree to use effective contraception during the study
You will not qualify if you...
- Known allergy to prednisone or immunosuppressive agents
- Active severe lupus nephritis within 8 weeks before screening requiring prohibited medications, hemodialysis, or high-dose steroids
- Suicidal thoughts within 6 months or suicidal behaviors within 12 months or recurrent lifetime suicidal behaviors
- Central nervous system diseases or changes related to SLE or non-SLE within 8 weeks before screening
- Other lupus crises within 8 weeks before screening
- Non-SLE inflammatory arthritis or skin diseases
- Severe vasculitis from diseases other than SLE
- History of vital organ or stem cell transplantation
- Plasmapheresis, hemodialysis, or intravenous immunoglobulin within 14 days before screening
- Other autoimmune diseases needing systemic treatment
- Active viral hepatitis B, positive hepatitis C, HIV, cytomegalovirus, Epstein-Barr virus, or syphilis
- Active or latent tuberculosis unless properly treated
- Severe lab abnormalities in liver, kidney, bone marrow, coagulation, lung, or heart functions
- Severe allergies or hypersensitivity to study drugs or related products
- Severe heart or hepatobiliary diseases
- Unstable or untreated medical conditions
- Uncontrolled infections requiring antibiotics
- Recent or planned live/attenuated vaccinations
- Recent use of Janus kinase or Bruton tyrosine kinase inhibitors
- Prior B-cell targeted therapy or biologics other than B-cell therapy within specific time frames
- Previous CAR-T or genetically modified T cell therapies
- Recent corticosteroid therapy before leukapheresis or infusion
- Other study drugs for SLE within 4 weeks before leukapheresis
- Major surgery recently or planned during the study
- Significant recent blood loss, transfusions, or planned blood donation
- Recent significant bleeding or need for continuous anticoagulants
- Severe mental illness
- Alcohol or drug abuse history
- Pregnant or breastfeeding women, or males with partners planning pregnancy within 2 years
- History of cancer
- Any other medical conditions or contraindications posing unacceptable risk per investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
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
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