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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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)
. 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).