RecruitingPhase 1NCT06978647

A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases

An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Diseases

Sponsor

China Immunotech (Beijing) Biotechnology Co., Ltd.

Enrollment

12 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)Systemic Lupus Erythematosus (SLE)Inflammatory Myopathy Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Antiphospholipid Syndrome (APS)Sjogren's Syndrome Systemic Sclerosis (SSc)IgG4-Related Diseases

Summary

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of CAR-T cell therapy (immune cells engineered to target a specific protein called CD19) for people with severe autoimmune diseases — such as lupus, Sjögren's syndrome, or inflammatory myositis — that have not responded to multiple standard treatments. The aim is to "reset" the immune system. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with relapsing or refractory systemic lupus erythematosus (SLE), Sjögren's syndrome, or another qualifying autoimmune disease - Your disease remains active despite trying at least two immunosuppressive medications - You have detectable CD19-positive B cells in your blood - Your organ function (blood counts, liver, kidney, heart) is within acceptable ranges **You may NOT be eligible if...** - You have severe disease of major organs not related to your autoimmune condition - You have cancer or a blood disorder - You are pregnant or breastfeeding - You have a known allergy to the study treatment components 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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