BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases
China50 participantsStarted 2024-12-26
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age, 18-65 years old (inclusive), weight \>=45kg, male and female;
✓. The diagnosis of each disease meets the following criteria:
✓. Patients with Behcet's disease must be active patients who meet the following conditions, and the active phase is defined as the emergence of new symptoms or the deterioration of existing symptoms, and one of the following conditions must be met:
✓. Patients with active inflammatory myopathy need to meet the following additional conditions:
✓. ANCA-associated vasculitis:
✓. Additional Enrollment Criteria for Systemic Sclerosis:
✓. Additional enrollment criteria for systemic lupus erythematosus A. The SLEDAI score of the patient before enrollment \>= 7 points B. Failure to receive the following treatments: oral prednisone \>=20 mg/d; Cyclophosphamide 0.4 to 0.6 g/m2 once every two weeks for 6 months, or other immunosuppressants such as mycophenolate mofetil 2 g/day for 3 months without remission.
✓. Additional enrollment criteria for antiphospholipid syndrome A. Cardiolipin antibody, lupus anticoagulant factor, and anti-β2-glycoprotein 1 antibody were all positive before enrollment.
Exclusion criteria
✕. Use of rituximab or other monoclonal antibodies within 1.6 months.
✕. Received high-dose glucocorticoids (\>1 mg/kg/d) within 1 month.
✕. Serious complications: including heart failure (\>= NYHA Class III), renal insufficiency (creatinine clearance \<=30 ml/min), hepatic insufficiency (serum ALT or AST greater than three times the upper limit of normal, or total bilirubin greater than the upper limit of normal)
What they're measuring
1
Systemic Lupus Erythematosus primary outcome
Timeframe: From enrollment to the end of treatment at 24 weeks
2
Sjogren syndrome primary outcome
Timeframe: From enrollment to the end of treatment at 24 weeks
3
Inflammatory Myopathy primary outcome
Timeframe: From enrollment to the end of treatment at 24 weeks
4
Systemic Sclerosis primary outcome
Timeframe: From enrollment to the end of treatment at 24 weeks
5
Behçet's Disease primary outcome
Timeframe: From enrollment to the end of treatment at 24 weeks
6
ANCA associated Vasculitis primary outcome
Timeframe: From enrollment to the end of treatment at 52 weeks
7
Antiphospholipid Syndrome primary outcome
Timeframe: From enrollment to the end of treatment at 52 weeks
✕. Other severe, progressive, or uncontrollable hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases (including demyelinating diseases such as multiple sclerosis).
✕. Known allergies, hyperreactivity, or intolerance to IL-2 or its excipients.
✕. Have a serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or hospitalization for infection, or use of intravenous antibiotics for treatment of infection 2 months prior to the first dose of treatment.
✕. Chest imaging showing malignancy or current activity within 3 months prior to the first use of study drug Abnormalities in sexually transmitted infections (including tuberculosis).
✕. Infection with HIV (HIV antibody-positive serology) or hepatitis C (Hep C antibody-positive serology).
Timeframe: From enrollment to the end of treatment at 52 weeks
9
IgG4-related Disease primary outcome
Timeframe: From enrollment to the end of treatment at 24 weeks