CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 6 target
Drug / intervention
YTS109other
Likely dose
Not stated in record
Key inclusion· 23
  • ✓Age 18-65 years old
  • ✓CD19 positive on flow cytometry
  • ✓SLE meeting EULAR/ACR 2019 criteria with specified disease activity
  • ✓Sjögren's syndrome meeting 2002 AECG or 2016 ACR/EULAR criteria
Key exclusion· 14
  • ✕Severe drug allergy or allergic constitution
  • ✕Uncontrolled fungal, bacterial, viral or other infections
  • ✕CNS disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy, CVA, encephalitis, CNS vasculitis)
  • ✕Cardiac dysfunction

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06379646
NCT06379646N/ARecruitingUpdate OverdueUpdated 22mo ago · Completion was 14mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease

China Immunotech (Beijing) Biotechnology Co., Ltd.·interventional·Posted Apr 23, 2024·Updated Aug 29, 2024

In Brief

A clinical study evaluating YTS109 for Systemic Lupus Erythematosus and 5 related conditions. Currently recruiting, targeting 6 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome, Sjogren's Syndrome
CountriesChina
CollaboratorsShanghai Changzheng Hospital

Timeline

N/ARecruitingOverdue
20252026
First PostedApr 23, 2024
Enrollment StartApr 24, 2024
Primary CompletionApr 21, 2025
Study CompletionApr 21, 2026
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 2.2 years ago

Interventions

YTS109other

Subjects will receive YTS109 Cell Injection(3E6STAR+T cell/kg) once in this study.