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

StatusRecruiting
PhasePhase 1
Started2025-04-16
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 13, 2025 (before its estimated April 25, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-05-08
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
PhaseEarly Phase 1→Phase 1
Start dateestimated 2025-04-25→confirmed 2025-04-16
Eligibility criteria+126 characters
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study: Age ranges from 18 to 65 years old (including threshold), re [...] dless of gender. Meet the EULAR/ACR 2019 SLE Classification Criteria Criteri: Cohort 1: Refractory Lupus Nephritis: Defined as failure to achieve remission after 3-6 months of treatment with corticosteroids and ≥2 immunosuppressants (e.g., corticosteroids, CTX, tacrolimus, MMF, cyclosporine) and/or biologics, with Urineurine protein/creatinine ratio (UPCR ≥1.0 g/g) , and renal pathology criteriarequirement scrite [...] [...]
Secondary endpoints6 entries, revised
Efficacy outcomesEvaluation forin SLELN Efficacy outcomesEvaluation forin Refractory thrombocytopeniaSLE-ITP
Primary endpoints1 entry, revised
Incidence of Treatment-Emergent Adverse Events [Safety]
Study description+1,324 characters
ThisBackground: studySystemic 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 bee [...] 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 in subjects with Refractory System [...] [...]
Collaborators-24 characters
Beijing GoBroad Hospital
Study title-32 characters
AnA Clinical Study of YTS109 Cell Injection in Subjects With RefractoryR/R Systemic Lupus Erythematosus
2025-04-17
Original filing
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.
Trial Details
NCT Number NCT06943937
Lead Sponsor China Immunotech (Beijing) Biotechnology Co., Ltd.
Conditions Lupus Nephritis (LN), Immune Thrombocytopenia (ITP)
Enrollment 36 participants
Start Date 2025-04-16
Primary Completion 2026-04-25 (estimated)
Study Completion 2027-04-25 (estimated)
Updated on ClinicalTrials.gov 2025-05-13