RecruitingPhase 1NCT07123519

A Clinical Study of YTS109 Cells for the Treatment of 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

18 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus (SLE)Lupus Nephritis (LN)Sjogren's Syndrome (SS)Inflammatory Myopathy Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Antiphospholipid Syndrome (APS)

Summary

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3E6 STAR -T cells/kg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent/refractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. 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 Institute of Hematology \& Blood Diseases Hospital.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called YTS109 — which uses genetically engineered T cells — to treat people with severe autoimmune diseases that have not responded to standard treatments. **You may be eligible if...** - You are 18–65 years old - You have one of the following autoimmune conditions that has not responded to multiple standard treatments: Lupus (SLE) with kidney involvement or severe low platelets; Sjögren's syndrome; Systemic sclerosis (scleroderma); Inflammatory myopathy (e.g., dermatomyositis or polymyositis); ANCA-associated vasculitis; Antiphospholipid syndrome - Your disease meets specific activity level criteria - You have adequate organ function **You may NOT be eligible if...** - You have active uncontrolled infections - You have a history of cancer in the past 5 years - You have end-stage kidney failure - You are HIV, active hepatitis B, or hepatitis C positive - You are pregnant or planning to become pregnant 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

DRUGYTS109 cell

Subjects will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3E6 STAR-T cells/kg, employing a 3+3 escalation principle for dose titration.