NCT07104721

A 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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 The First Affiliated Hospital of Anhui Medical University.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Lupus Nephritis (LN)
• Systemic Sclerosis (SSc)
• Inflammatory Myopathy
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Antiphospholipid Syndrome (APS)

Interventions

Type	Name	Description
DRUG	YTS109 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.

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-08-04
• Completion: 2028-12-30
• First posted: 2025-08-05
• Last updated: 2026-03-02

Locations

1 site across 1 country: China