NCT06943937

A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus

An Exploratory Clinical Study of YTS109 Cell in Subjects With Refractory Disease Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 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.

Detailed description

Background: Systemic lupus erythematosus (SLE) is characterized by multi-system and multi-organ involvement, recurrent flares and remissions, and the presence of numerous autoantibodies. LN and SLE-ITP are the most common and severe clinical manifestations of SLE. Recently, the therapeutic advancements have been made in the management of SLE. However, the patients with refractory SLE, particularly those complicated by LN and SLE-ITP, continue to face significant unmet clinical needs. CAR-T cell therapy has emerged as one of the innovative therapeutic modalities for autoimmune diseases, characterized by its controllable safety profile and durable therapeutic efficacy, warranting further clinical exploration and investigation in the future. YTS109 cell is a universal allogeneic STAR-T cell therapy targeting CD19, designed to efficiently eliminate B cells in patients with SLE and mitigate autoimmune responses. Design: This is a single-center, single-arm, prospective exploratory clinical trial designed to evaluate the safety profile, preliminary therapeutic efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of YTS109 cell therapy in patients with refractory SLE. 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). This study was approved by the IRB of Beijing GoBroad Hospital (Approval Number: RP2025-013-002), All participants provided written informed consent.

Conditions

• Lupus Nephritis (LN)
• Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	YTS109 cell injection	Subjects will receive YTS109 Cell Injection(1E6 STAR+T cell/kg or 2E6 STAR+T cell/kg) once in this study.

Timeline

• Start date: 2025-04-16
• Primary completion: 2026-04-25
• Completion: 2027-04-25
• First posted: 2025-04-25
• Last updated: 2025-05-13

Locations

1 site across 1 country: China