Actively Recruiting
A Clinical Study Evaluating Safety and Effects of CD19 CAR-T Cell Infusion in Adults with 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
Researchers are evaluating the safety and effectiveness of CD19 CAR-T cell therapy in adults with active systemic lupus erythematosus (SLE), a condition that remains difficult to control with current treatments like glucocorticoids and immunosuppressive agents. This study aims to address the challenges of persistent disease activity and the side effects caused by long-term glucocorticoid use by investigating this new treatment in a clinical trial setting. The study is a Phase 1/2 trial focusing on safety, tolerability, and preliminary efficacy of the CD19 CAR-T therapy. Participants will receive an intravenous infusion of CD19 CAR-T cells, a biological treatment designed to target specific immune cells involved in SLE. After the infusion, they will be followed for up to two years to monitor the treatment's effects and any side effects. The study includes a detailed treatment and follow-up schedule to assess the therapy’s impact over time. During the study, participants will undergo various evaluations including clinical assessments, laboratory tests, and monitoring for safety and treatment response. Researchers will specifically measure safety and tolerability within two years after the infusion, tracking any adverse events or complications. The comprehensive follow-up aims to provide detailed information on the treatment’s effects and long-term safety in patients with active SLE.
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
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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