RecruitingPhase 1Phase 2NCT06828042

Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases

A Single-center Clinical Study Evaluating the Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells(QH103) in Refractory Autoimmune Diseases


Sponsor

Peking University Third Hospital

Enrollment

9 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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(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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called CAR-γδT cells — specially engineered immune cells that target a protein called CD19 found on abnormal immune cells — for people with severe autoimmune diseases that have not responded to standard treatments. **You may be eligible if...** - You are between 18 and 80 years old - You have a confirmed autoimmune disease (such as lupus, myositis, scleroderma, or similar conditions) - Your disease is considered refractory — meaning it hasn't responded to conventional treatments for more than 6 months, or it has relapsed after remission - CD19 is detectable on your B cells (a type of immune cell) by blood testing **You may NOT be eligible if...** - You have active, uncontrolled infection - You have significant organ failure (heart, liver, kidney, or lung) - You have a history of certain prior therapies that could interfere with this treatment - You are pregnant or breastfeeding - You have a history of cancer (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALanti-CD19 CAR T cell therapy

anti-CD19 CAR-γδ T cell therapy


Locations(1)

Peking University Third Hospital

Beijing, China

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NCT06828042


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