Actively Recruiting
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
Led by Peking University Third Hospital · Updated on 2025-08-20
9
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. 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. Chimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.
CONDITIONS
Official Title
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, male or female
- Positive CD19 expression on peripheral blood B cells by flow cytometry
- Diagnosed with refractory autoimmune disease with ineffective conventional treatment for over 6 months or disease recurrence after remission
- Currently on stable doses of glucocorticoids, antimalarials, immunosuppressants, or biologics with specific stability periods
- Female participants of childbearing potential and male participants with partners of childbearing potential must use contraception or abstain during treatment and for 6 months after
- Female participants must have a negative serum HCG test within 7 days before enrollment and not be breastfeeding
- Willing to participate and sign informed consent
- Meet specific disease criteria for Systemic Lupus Erythematosus, Sj�f6gren's Syndrome, Systemic Sclerosis, Inflammatory Myopathies, ANCA-Associated Vasculitis, or Refractory Antiphospholipid Syndrome as detailed in the protocol
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Uncontrolled or treatment-requiring infections (fungal, bacterial, viral, or other)
- Central nervous system diseases including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis
- Major organ dysfunction not related to autoimmune disease with specific criteria for bone marrow, liver, kidney, coagulation, and cardiac function
- Congenital immunoglobulin deficiencies
- History of malignancy within the past 5 years
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with active infections
- Psychiatric disorders or severe cognitive impairment
- Participation in other clinical trials within 3 months prior to enrollment
- Previous treatment with CAR-T therapy
- History of severe adverse reactions to cyclophosphamide or fludarabine
- Any other condition deemed by investigators as exclusionary
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaoying Zhang
CONTACT
X
Xiaoying Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here