Actively Recruiting
A Single-center Clinical Study Evaluating the Safety and Efficacy of CD19 Universal CAR-b3b4T Cells 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 studying CD19 Universal CAR-b3b4T cells as a potential treatment for adults with active severe systemic lupus erythematosus (SLE), a condition where current therapies often fail to fully control disease activity. This study aims to assess the safety, tolerability, early effectiveness, and how the body processes and responds to these CAR-T cells. The trial is led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants will receive an intravenous infusion of CD19 Universal CAR-b3b4 T Cells. The study includes a treatment phase where the cells are given, followed by a long-term follow-up period lasting up to two years. During this time, researchers will monitor various health and disease activity markers to understand the treatment's effects. Throughout the study, participants will have regular visits for assessments including safety checks, disease activity scores (SELENA-SLEDAI and Physician Global Assessment), immunological tests, and levels of specific antibodies in the blood. Researchers will track these outcomes at multiple time points up to 24 months after infusion. This follow-up ensures close monitoring of participant health and how the therapy interacts with their condition over time.
CONDITIONS
Brief Title
A Clinical Study of CD19 Universal CAR-γδT Cells 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 and follow-ups 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 American College of Rheumatology 1997 criteria at least 24 weeks before consent
- Active SLE indicated by SELENA-SLEDAI score of 6 or higher and Physician Global Assessment (PGA) score of 1 or higher at screening
- Received at least 8 weeks of standard SLE treatment before screening
- Female participants must have a negative pregnancy test and agree to 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 prednisone
- Suicidal thoughts in past 6 months or suicidal behavior in past 12 months or recurrent history
- Central nervous system diseases or changes related to SLE or other causes within 8 weeks before screening
- Other lupus crises within 8 weeks before screening
- Diagnosis of non-SLE inflammatory arthritis or skin diseases
- Severe vasculitis from other diseases excluding SLE
- History of organ or stem cell transplantation
- Received plasmapheresis, hemodialysis, or intravenous immunoglobulin within 14 days before screening
- Other autoimmune diseases requiring systemic therapy
- Active or latent tuberculosis not properly treated
- Severe abnormalities in liver, kidney, bone marrow, coagulation, lung, or heart function
- Severe allergies to study drug components or related products
- Severe heart or hepatobiliary diseases
- Unstable or untreated medical conditions
- Uncontrolled infections needing antibiotics
- Recent or planned live/attenuated vaccinations
- Recent use of Janus kinase inhibitors, Bruton tyrosine kinase inhibitors, or certain biologics
- Previous CAR-T cell or genetically modified T cell therapy
- Recent corticosteroid therapy before leukapheresis or infusion
- Recent major surgery or unhealed surgical wounds
- Recent significant blood donation, blood loss, or transfusion
- Recent serious bleeding or need for long-term anticoagulants
- Severe mental illness
- Alcohol or drug abuse history
- Pregnancy, lactation, or plans for pregnancy within 2 years after infusion
- History of cancer
- Other medical conditions posing unacceptable risk as judged by investigators
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 with follow-up assessments
Participants receive an intravenous infusion of CD19 Universal CAR-γδ T Cells as treatment for active systemic lupus erythematosus.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and disease activity for up to 2 years after the infusion.
Visits at day 14, day 28, month 3, month 6, month 9, month 12, month 18, and month 24
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
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