Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the T… (NCT06821659) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases
9 participantsStarted 2025-03-01
Plain-language summary
Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy. Clinical studies are exploring the use of CD19-targeting CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, we investigate the safety and efficacy of universal CD19-targeting CAR T cells in the treatment of autoimmune diseases.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age between 18-80 years (inclusive), male or female.
✓. \>40kg.
✓. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.
✓. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg/day prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \>5 mg/day prednisone (or an equivalent dose). If the subject is receiving antimalarials and/or conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.
✓. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.
What they're measuring
1
Evaluate the safety of UWD-CD19 cell injection in the treatment of refractory autoimmune diseases.
✓. Willing to participate in the trial and sign the informed consent form.
✓. Meets the 2019 EULAR/ACR classification criteria for SLE.
✓. ANA titer ≥1:80, or positive for anti-dsDNA and/or anti-Sm antibodies.
Exclusion criteria
✕. Subjects with a history of alcohol abuse or substance abuse within the past 24 weeks;
✕. Subjects with other psychiatric disorders such as schizophrenia or major depressive disorder;
✕. Subjects with a history of malignancies other than B-cell lymphoma;
✕. Subjects with overlapping diseases that affect the assessment of disease activity;
✕. Subjects with infections such as human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency virus infection, or chronic hepatitis B or C;
✕. Subjects with known active tuberculosis (TB) infection or bacterial infections;
✕. Subjects with a history of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, active arrhythmia, or other clinically significant heart diseases within 6 months prior to screening;
✕. Subjects with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;