Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases

Sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Study ID
NCT07236801
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • YTS109 cell — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
Oct 2025
Primary completion
Nov 13, 2026
Completion
Nov 13, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: YTS109 cell

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: The efficacy endpoint evaluation for 2, 4, 8, 12 weeks, AEs observation will be follow-up for 24 weeks. The observation period is extended to 52 weeks. ]

Central Contacts

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