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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06978647

Run by

China Immunotech (Beijing) Biotechnology Co., Ltd.

People needed

12

Starts

2025-05-19

Expected to finish

2027-05-19

Last updated by the study team

2025-07-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:
• Common inclusion criteria:
• 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.
• Specific inclusion criteria:
• 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;
• Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;
• Testing positive for anti-SSA/Ro antibodies;
• 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;
• Testing positive for systemic sclerosis-related antibodies;
• Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);

You may not qualify if…

• Subjects who meet any of the following exclusion criteria will not be admitted to the study:
• 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;
• Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.

Where it is running

• The First Medical Center of Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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