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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
ClinicalTrials.gov ID: NCT06978647
What this study is testing
What is YTS109 cell?
YTS109 cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus (sle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people must meet both the following common and disease-specific simultaneously to be eligible for participation in this study: Common
- 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:
- Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use). Hemoglobin ≥60 g/L.
You likely can't join if
- people 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;
- people with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes...
- people whose cardiac function cannot tolerate the study interventions;
- people with congenital immunoglobulin deficiencies;
See the full eligibility criteria
Who can join
- people must meet both the following common and disease-specific simultaneously to be eligible for participation in this study: Common
- 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:
- 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...
- 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...
- 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);
- 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...
- 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...
- Meeting the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase...
- Testing positive for myositis-specific antibodies;
- For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's...
- 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...
- Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia. Note: Meeting either criterion 4 or 5 is sufficient. Relapsing and refractory Anti-Neutrophil...
- Meeting the 2022 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis...
- Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).
- A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.
- Definition of relapsing/refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of...
- Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for IgG4-related disease (IgG4-RD);
- Having an IgG4-RD responder index (RI) ≥ 2 during the screening period, indicating active disease;
- Meeting the criteria for refractory or relapsing IgG4-RD: 1) Refractory: Defined as a lack of response to steroid therapy or steroid plus immunosuppressive therapy (no clinical or radiological improvement, with a...
What rules you out
- people 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;
- people 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...
- people whose cardiac function cannot tolerate the study interventions;
- people with congenital immunoglobulin deficiencies;
- people with a history of malignant tumors within the past five years;
- people with end-stage renal failure;
- people 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; people who are positive for hepatitis C...
- people with psychiatric disorders or severe cognitive dysfunction;
- people who have participated in other clinical trials within the past three months prior to enrollment;
- people 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;
- people whom the investigator believes have other reasons that preclude their inclusion in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.