A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Immunotech (Beijing) Biotechnology Co., Ltd.
About this trial
This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells/kg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints include the complete renal response (CRR) rate at week 12 in LN, and proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP. This single-arm, open-label trial will enroll patients across Beijing GoBroad Hospital in China.
Eligibility criteria
Qualifiers
Age ranges from 18 to 65 years old (including threshold), regardless of gender.
Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).
Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL
Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
Disqualifiers
Severe drug allergies or hypersensitivity.
Uncontrolled/untreated infections (fungal, bacterial, viral, etc.).
CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).
Heart failure intolerance.
Trial design
Treatments tested in this trial
- YTS109 cell injection
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov