Actively Recruiting
A Single-center Clinical Study Evaluating the Safety and Efficacy 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
104 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
Researchers are investigating the safety and effectiveness of CD19 CAR-T cell therapy for adults with active systemic lupus erythematosus (SLE), a disease where current treatments often struggle to control symptoms or cause serious side effects. This study aims to address the need for better treatment options by exploring how this cell therapy works and how well patients tolerate it. It is a Phase 1 and Phase 2 clinical trial conducted by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants in the study will receive an intravenous infusion of CD19 CAR-T cells. After the infusion, patients will be followed for up to two years. The study involves monitoring various outcomes including safety, how the therapy moves and acts in the body, and changes in disease activity and immune markers. Regular assessments will take place at multiple time points during the follow-up period to track response and side effects. During the study, participants will have scheduled visits for clinical evaluations, blood tests, and questionnaires to measure disease activity and immune system changes. Researchers will look at safety and tolerability over two years, along with detailed lab tests such as antibody levels, complement proteins, and lupus severity indexes. This long-term follow-up helps understand the therapy’s effects and any risks, supporting comprehensive monitoring of participant health throughout the study.
CONDITIONS
Brief 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
- Age between 18 and 70 years, any gender
- Body weight of at least 40 kg
- Diagnosed with systemic lupus erythematosus (SLE) according to ACR 1997 criteria at least 24 weeks before consent
- Active SLE with SELENA-SLEDAI score of 6 or higher and PGA score of 1 or higher at screening
- Have received at least 8 weeks of standard treatment for SLE before screening
- Female participants 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 or high-dose steroids
- Suicidal thoughts or behaviors within recent months
- Central nervous system diseases related or unrelated to SLE within 8 weeks before screening
- Other lupus crises within 8 weeks before screening
- Non-SLE inflammatory arthritis or skin diseases
- Severe vasculitis from other causes excluding SLE
- History of vital organ or stem cell transplantation
- Recent plasmapheresis, hemodialysis, or intravenous immunoglobulin within 14 days before screening
- Other autoimmune diseases needing systemic treatment
- Active infections including hepatitis B, C, HIV, CMV, EBV, or syphilis
- Active or latent tuberculosis unless treated
- Severe lab abnormalities affecting liver, kidney, bone marrow, coagulation, lung, or heart
- Severe allergies or hypersensitivity to study drug components
- Severe heart or liver disease
- 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 (except B-cell therapies) within specified periods
- Previous CAR-T or genetically modified T cell therapies
- Recent corticosteroids, other study drugs, or major surgery
- Recent significant blood loss, transfusions, or planned blood donation
- Recent severe bleeding or need for long-term blood thinners
- Severe mental illness, alcoholism, or drug abuse
- Pregnant or lactating females or intent for pregnancy within 2 years after infusion
- History of cancer
- Other conditions posing unacceptable risk as judged by investigators or clinical criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion
Participants receive CD19 CAR-T cell intravenous infusion as treatment for active systemic lupus erythematosus.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are followed for up to 2 years after infusion to monitor safety, efficacy, and changes in disease activity and immunological markers.
Multiple follow-up visits on day 14, day 28, and months 3, 6, 9, 12, 18, and 24 (in-person)
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Q
Qiubai Li, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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