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Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases

NCT07236801 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-03-02

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), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells/kg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent/refractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. 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 The First Affiliated Hospital of Anhui Medical University.

Conditions

  • Systemic Lupus Erythematosus (SLE)
  • Systemic Sclerosis
  • Sjogren's Syndrome (SS)
  • Inflammatory Myopathy
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  • Antiphospholipid Syndrome

Interventions

DRUG

YTS109 cell

Subjects will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells/kg, employing a 3+3 escalation principle for dose titration.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    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
2025-11-13
Primary Completion
2026-11-13
Completion
2027-11-13

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07236801 on ClinicalTrials.gov