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Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases

NCT06821659•Peking University Third Hospital

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18-80 years (inclusive), male or female.
•2. \>40kg.
•3. 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.
•4. 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.
•5. 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.
•6. Willing to participate in the trial and sign the informed consent form.
•Systemic Lupus Erythematosus (SLE):
•1. Meets the 2019 EULAR/ACR classification criteria for SLE.
•2. ANA titer ≥1:80, or positive for anti-dsDNA and/or anti-Sm antibodies.
•3. Disease activity score (SLEDAI-2000) ≥8.
+16 more criteria

Exclusion Criteria

•1. Subjects with a history of alcohol abuse or substance abuse within the past 24 weeks;
•2. Subjects with other psychiatric disorders such as schizophrenia or major depressive disorder;
•3. Subjects with a history of malignancies other than B-cell lymphoma;
•4. Subjects with overlapping diseases that affect the assessment of disease activity;
•5. Subjects with infections such as human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency virus infection, or chronic hepatitis B or C;
•6. Subjects with known active tuberculosis (TB) infection or bacterial infections;
•7. 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;
•8. Subjects with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
•9. Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels ≥3×ULN, or bilirubin \>1.5×ULN, excluding abnormalities caused by theautoimmune disease;
•10. Subjects with chronic kidney failure stage 4 or above, defined as an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or serum creatinine \>2.5 mg/dL;
+8 more criteria

Key Dates

Start Date

March 1, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

February 12, 2025

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus ErthematosusSystemic Sclerosis (SSc)Inflammatory MyopathiesANCA Associated Vasculitis (AAV)Sjogren Syndrome

Interventions

anti-CD19 CAR-T cells

BIOLOGICAL

Contacts

Xiaoying Zhang

CONTACT

86+13810001444 zhang_xiaoying@pku.edu.cn

Xiaoying Zhang

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases

Inclusion Criteria

Exclusion Criteria

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