Condition: Systemic Lupus Erythematosus (SLE) · Lupus Nephritis (LN) · Systemic Sclerosis (SSc) · Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.
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.
This description comes directly from the study's public registry record.
Huan Zhou · 86-13665527160 · zhouhuanbest@vip.163.com
Zhili Wu · 86-13075536703 · 13075536703@163.com
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| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07104721