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

NCT06978647 | Recruiting Phase 1

• 1 other identifier: YTS109-006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  1. Efficacy Endpoint； 2. Types, severity, and frequency of adverse events (AEs).

  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.

Secondary Outcomes (6)

• Efficacy Evaluation in relapsed/refractory autoimmune diseases

  2, 4, 8, 12 weeks, and the observation will continue until 24 to 52 weeks post-treatment.

• Maximum Plasma Concentration of YTS109 (Cmax)

  The detections will be conducted on day0, 4, 7, 10, and weeks 2, 3, 4. Then, observation will continue until 12 to 24 weeks post-treatment.

• Area Under the Plasma Concentration-Time Curve (AUC) of YTS109

  The detections will be conducted on day0, 4, 7, 10, and weeks 2, 3, 4. Then, observation will continue until 12 to 24 weeks post-treatment.

• Time to Reach Maximum Plasma Concentration (Tmax) of YTS109

  The detections will be conducted on day0, 4, 7, 10, and weeks 2, 3, 4. Then, observation will continue until 12 to 24 weeks post-treatment.

• PD Biomarker Level Change (Cytokines Concentration)

  The detections will be conducted on day0, 4, 7, 10, and weeks 2, 3, 4. Then, observation will continue until 24 to 52 weeks post-treatment.

Study Arms (1)

YTS109 cell

EXPERIMENTAL

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

Drug: YTS109 cell

Interventions

YTS109 cell DRUG

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

YTS109 cell

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranges from 18 to 65 years old (including threshold), regardless of gender.
• Detection of positive CD19 expression on peripheral blood B cells by flow cytometry.
• Essential Organ Function Criteria:
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• Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).
• Hemoglobin ≥60 g/L.
• Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted).
• Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
• Coagulation: INR/PT ≤1.5×ULN.
• Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.
• \. Voluntary participation with signed informed consent and compliance.
• Relapsing and refractory systemic lupus erythematosus:
• \. Meeting the EULAR/ACR 2019 SLE Classification Criteria; 2. SELENA SLEDAI≥6, or the presence of significant organ involvement, such as lupus nephritis (LN), etc; 3. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing treatment with a regimen containing at least two immunosuppressive agents (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolate mofetil (MMF), and cyclosporine) and/or biological agents for a minimum duration of two months.
• Relapsing and refractory Sjögren's syndrome:
• Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for primary Sjögren's syndrome;

You may not qualify if:

• Individuals with a severe history of drug allergies or those with an allergic constitution;
• Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
• Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);
• Subjects whose cardiac function cannot tolerate the study interventions;
• Subjects with congenital immunoglobulin deficiencies;
• Subjects with a history of malignant tumors within the past five years;
• Subjects with end-stage renal failure;
• Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;
• Subjects with psychiatric disorders or severe cognitive dysfunction;
• Subjects who have participated in other clinical trials within the past three months prior to enrollment;
• Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;
• Pregnant women or women planning to become pregnant;

Sponsors & Collaborators

• China Immunotech (Beijing) Biotechnology Co., Ltd.: lead
• The First Medical Center of Chinese PLA General Hospital: collaborator

Study Sites (1)

The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic; Myositis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antiphospholipid Syndrome; Arthritis, Rheumatoid; Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Arthritis; Joint Diseases; Rheumatic Diseases

Central Study Contacts

Jian Zhu

CONTACT

8610-66937166; jian_jzhu@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): May 19, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-05

Locations

CN (1)