MedTrace Logo

A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases

NCT06978647 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-07-14

No results posted yet for this study

Summary

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.

Conditions

  • Systemic Lupus Erythematosus (SLE)
  • Systemic Sclerosis (SSc)
  • Inflammatory Myopathy
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  • Antiphospholipid Syndrome (APS)
  • Rheumatoid Arthritis (RA)
  • IgG4-Related Diseases
  • Sjogren's Syndrome

Interventions

DRUG

YTS109 cell

Subjects will receive YTS109 cell (1.5 E6 STAR +T cells/kg) once in this study.

Sponsors & Collaborators

  • The First Medical Center of Chinese PLA General Hospital

    collaborator OTHER

  • China Immunotech (Beijing) Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2026-05-19
Completion
2027-05-19

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978647 on ClinicalTrials.gov