A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Status:
RECRUITING
Trial end date:
2027-05-19
Target enrollment:
Participant gender:
Summary
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.510 cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. 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 Chinese People's Liberation Army (PLA) General Hospital.
Phase:
PHASE1
Details
Lead Sponsor:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborator:
The First Medical Center of Chinese PLA General Hospital