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An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease

StatusUnknown
PhaseNot applicable
Started2024-04-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 29, 2024 (before its estimated April 21, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2024-08-27
Study Status, Outcome Measures v2
Trial statusRecruiting→Unknown
Primary endpoints7 entries, revised
Incidence of Treatment-Emergent Adverse Events [Safety outcomesand Tolerability]
2024-08-25
Not Yet Recruiting→Recruiting Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-04-22→confirmed 2024-04-24
Study sites0→1
Eligibility criteria+58 characters
[...] ety of Rheumatology (EULAR/ACR) SLE; Disease activity score SELENA SLEDAI-2000≥6 with at least one Injima Lupus Assessment Group Index (BI [...] sentation) organ scores, or both; Or disease activity score SELENA SLEDAI-2000 score ≥8; Definition of relapse refractory: conventional tr [...] infections that cannot be controlled or require treatment; CentralSubjects with central nervous system diseases caused by or not caused by ADsdisorders (includingexcluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cereb [...] ar accident, encephalitis, central nervous system vasculitis as a result of the [...] [...]
Secondary endpoints4 to 10 entries
Efficacy outcomes for SLE Efficacy outcomes for Sjogren's Syndrome Efficacy outcomes for Systemic Sclerosis Efficacy outcomes for Inflammatory Myopathy Efficacy outcomes for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Efficacy outcomes for Antiphospholipid Syndrome
Study description-111 characters
[...] n the treatment of recurrent/refractory autoimmune diseases. Interim analysis will be performed when participants finish the visit of 12 weeks after STAR-T cells infusion.
2024-04-17
Original filing
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
Trial Details
NCT Number NCT06379646
Lead Sponsor China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborators: Shanghai Changzheng Hospital
Conditions Systemic Lupus Erythematosus, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome, Sjogren's Syndrome
Enrollment 6 participants
Start Date 2024-04-24
Primary Completion 2025-04-21 (estimated)
Study Completion 2026-04-21 (estimated)
Updated on ClinicalTrials.gov 2024-08-29