A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases

NCT07123519 | Recruiting Phase 1

• 1 other identifier: YTS109-007
• Study Type: interventional
• Target: 18
• 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), 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 3E6 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 Institute of Hematology \& Blood Diseases Hospital.

Conditions

Systemic Lupus Erythematosus (SLE); Lupus Nephritis (LN); Sjogren's Syndrome (SS); Inflammatory Myopathy; Antiphospholipid Syndrome (APS); Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Keywords

Relapsing/Refractory Autoimmune Diseases

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

Subjects will receive YTS109 cell once in this study.

Drug: YTS109 cell

Interventions

YTS109 cell DRUG

Subjects will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3E6 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:
• 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). 2.4 Coagulation: INR/PT ≤1.5×ULN. 2.5 Cardiovascular: Hemodynamic stability.
• 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); 1.2 Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows: 1.2.1 Refractory Lupus Nephritis:(1)Failure 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.). (2)Urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g or 24-hour urine protein excretion \>1.0 g at screening. (3)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.
• 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; 2.2 Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6; 2.3 Testing positive for anti-SSA/Ro antibodies; 2.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.
• Relapsing and refractory Sjogren's Syndrome:
• Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis; 3.2 Testing positive for systemic sclerosis-related antibodies; 3.3 Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 3.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 3.5 Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).
• Note: Meeting either criterion 4 or 5 is sufficient.
• Relapsing and refractory Inflammatory Myopathy:

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
• Institute of Hematology & Blood Diseases Hospital, China: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis; Myositis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antiphospholipid Syndrome; Recurrence; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ying Wang

CONTACT

15900225626; wangying1@ihcams.ac.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: August 8, 2025
• First Posted: August 14, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): August 13, 2026
• Study Completion (Estimated): August 13, 2027
• Last Updated: March 2, 2026

Record last verified: 2025-08

Locations

CN (1)