Actively Recruiting
An Open, Single-Arm, Single-Center Study of BCMA-CD19 CAR-T Therapy for Multiple Refractory Autoimmune Diseases
Led by Peking University People's Hospital · Updated on 2025-04-02
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of BCMA-CD19 chimeric antigen receptor (CAR)-modified T cells in adults with multiple refractory autoimmune diseases that have not responded to other treatments. This open-label, single-center, single-arm Phase 2 study focuses on various autoimmune conditions including systemic lupus erythematosus, Sjogren syndrome, inflammatory myopathy, systemic sclerosis, Behcet's disease, ANCA-associated vasculitis, antiphospholipid syndrome, acquired thrombotic thrombocytopenic purpura, and IgG4-related disease. The study aims to assess the complete remission rate and laboratory markers as primary outcomes, along with pharmacokinetics, long-term effectiveness, and safety as secondary outcomes. Participants receive a single intravenous dose of BCMA-CD19 targeted CAR-T cells at 3×10^6 cells per kilogram of body weight, administered 1 to 2 days after preconditioning. The total volume infused ranges from approximately 10 to 70 mL. This single-dose treatment is followed by monitoring for clinical and laboratory improvements to evaluate treatment effects. The study spans up to 52 weeks depending on the specific autoimmune condition being treated. Throughout the study, participants undergo regular evaluations of clinical signs, laboratory tests, and pharmacokinetic assessments to track safety and efficacy. Outcome measures are collected from enrollment through either 24 or 52 weeks depending on the disease. Participants must adhere to stable doses of glucocorticoids and disease-modifying drugs during the trial. The study includes long-term safety monitoring and requires informed consent and contraception use for participants who may have children. Total participation lasts up to about one year from enrollment.
CONDITIONS
Brief Title
BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years inclusive, weight 45 kg or more, male or female
- Diagnosed with one of the specified autoimmune diseases meeting accepted classification criteria
- Multiple prior treatment regimens have been ineffective
- Stable use of glucocorticoids (≤1 mg/kg/day prednisone or equivalent) and disease-modifying drugs for at least 4 weeks before study drug
- Voluntary participation with signed informed consent
- Willingness to use effective contraception if of childbearing potential
- Disease-specific activity criteria met for Behcet's disease, inflammatory myopathy, ANCA-associated vasculitis, systemic sclerosis, systemic lupus erythematosus, antiphospholipid syndrome, Sjogren's disease, or IgG4-related disease as detailed in protocol
You will not qualify if you...
- Use of rituximab or other monoclonal antibodies within 1.6 months before treatment
- High-dose glucocorticoids (>1 mg/kg/day) within 1 month before treatment
- Serious complications such as heart failure (NYHA Class III or higher), severe renal or liver insufficiency
- Severe or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases
- Known allergies or intolerance to IL-2 or its components
- Serious infections or recent hospitalization for infection within 2 months before treatment
- Recent malignancy or current active malignancy within 3 months
- Positive for HIV or hepatitis C infection
- Uncontrolled mental or emotional disorders or recent substance abuse
- Recent or planned live vaccine administration within specified timeframes
- Pregnant or lactating women unwilling to use approved contraception
- Males unwilling to use approved contraception if partner is of childbearing potential
- Additional disease-specific exclusions such as certain myopathies or antibody positivity for ANCA-associated vasculitis
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 - Up to 24 to 52 weeks depending on disease type
Participants receive a single intravenous infusion of BCMA-CD19 CAR-T cells following preconditioning. The treatment is administered rapidly on day 0.
1 treatment visit and multiple follow-up visits for assessment during treatment period
Trial Site Locations
Total: 1 location
1
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
J
Jing He
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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