Actively Recruiting
BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases
Led by Peking University People's Hospital · Updated on 2025-04-02
50
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.
CONDITIONS
Official 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 old, weighing at least 45 kg, male or female
- Diagnosis meeting specific criteria for Systemic Lupus Erythematosus, Sjogren's Syndrome, Inflammatory Myopathies, Systemic Sclerosis, Behcet's Disease, ANCA-associated Vasculitis, IgG4-related Disease, Antiphospholipid Syndrome, or Acquired Thrombotic Thrombocytopenic Purpura
- Multiple prior treatments have been ineffective
- Stable use of glucocorticoids (\u22641 mg/kg/day prednisone or equivalent) and DMARDs for at least 4 weeks before starting study treatment, with no dose increases during the study
- Voluntary participation with signed informed consent
- Agreement to use effective contraception during the study if of childbearing potential
- Additional specific disease activity criteria based on each autoimmune condition, such as active symptoms or lab test thresholds
You will not qualify if you...
- Use of rituximab or other monoclonal antibodies within 1.6 months
- Use of high-dose glucocorticoids (>1 mg/kg/day) within 1 month
- Serious heart failure (NYHA Class III or higher), severe kidney or liver dysfunction
- Severe or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or brain diseases
- Allergy or intolerance to IL-2 or its ingredients
- Serious infections or recent hospitalization for infection within 2 months
- Malignancy or active cancer within the last 5 years, except certain skin or cervical cancers
- HIV or hepatitis C infection
- Uncontrolled mental or emotional disorders, recent drug or alcohol abuse
- Recent or planned live vaccinations within specified timeframes
- Pregnant or breastfeeding women unwilling to use contraception
- Males unwilling to use contraception if their partner can have children
- Additional exclusions for inflammatory myopathies and ANCA-associated vasculitis as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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