Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases

NCT07236801 | Recruiting Phase 1

• 1 other identifier: YTS109-009
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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), 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  1. Types, severity, and frequency of adverse events (AEs); 2. Incidence of dose-limiting toxicity (DLT).

  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, 8, 12. 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, 8, 12. 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, 8, 12. Then, observation will continue until 12 to 24 weeks post-treatment.

• Cytokines Concentration Level Change

  The detections will be conducted on day0, 4, 7, 10, and weeks 2, 3, 4, 8, 12. Then, observation will continue until 24 to 52 weeks post-treatment.

Study Arms (1)

YTS109 cell

EXPERIMENTAL

Drug: YTS109 cell

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.

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.
• 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. 3. 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 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for systemic lupus erythematosus (SLE); 2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:
• Refractory Lupus Nephritis:
• ①Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \[CTX\], tacrolimus, mycophenolate mofetil \[MMF\], and cyclosporine) and/or biologic agents (including rituximab, belimumab, telitacicept, etc.).
• Urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g or 24-hour urine protein excretion \>1.0 g at screening.
• Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.

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;
• History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;
• 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 Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (2)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic; Sjogren's Syndrome; Myositis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular

Central Study Contacts

Dongmei Zhou

CONTACT

15252002644; zdm@xzhmu.edu.cn

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: November 15, 2025
• First Posted: November 19, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2027
• Last Updated: March 2, 2026

Record last verified: 2025-10

Locations

CN (2)