RecruitingPhase 1NCT07236762

An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases

An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Subjects With Relapsing/Refractory Autoimmune Diseases

Sponsor

China Immunotech (Beijing) Biotechnology Co., Ltd.

Enrollment

18 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

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 3×10⁶ 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 Bengbu Third People's Hospital.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell-based therapy called YTS109 — which uses engineered immune cells — to treat people with autoimmune diseases that have not responded to standard treatments. Autoimmune diseases are conditions where the immune system mistakenly attacks the body's own tissues. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed autoimmune disease (specific subtypes will be listed in the study details) that has not responded to other treatments - Your blood counts, liver, kidney, and heart function meet minimum requirements **You may NOT be eligible if...** - You have active serious infections - You are pregnant or planning to become pregnant - Your organ function does not meet the minimum requirements - You have other conditions that make participation unsafe 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 3×10⁶ STAR -T cells/kg, employing a 3+3 escalation principle for dose titration.