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Study identifier: NCT07236762 Synced from ClinicalTrials.gov · July 28, 2026
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An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases

Condition: Systemic Lupus Erythematosus · Lupus Nephritis (LN) · Sjogren's Syndrome  ·  Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

PhasePhase 1
Planned participants18
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Hanwei Wang  ·  13955281350  ·  whw2139@sina.com

Always discuss trial participation with your own doctor first.

Locations (1)

The third people's Hospital of BengbuBengbu, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07236762