ClinicalTrials.gov record NCT06978647

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Diseases

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old to 65 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1, single-arm study gives one infusion of YTS109 cells (1.5×10^6 cells/kg) to about 6–12 adults aged 18–65 with relapsed or refractory autoimmune diseases (for example SLE, SSc, RA, Sjögren's, APS, inflammatory myopathy, ANCA-associated vasculitis, or IgG4‑RD). The study monitors adverse events, early measures of response, and pharmacokinetic/pharmacodynamic markers with follow-up planned for 24 to 52 weeks.

What it is studying. The study is testing the safety (types, severity, and frequency of adverse events), preliminary efficacy, and the pharmacokinetic/pharmacodynamic behavior of a single infusion of allogeneic YTS109 STAR-T cells, including effects on B cells and cytokines.

What the researchers hope to learn. To evaluate the safety profile and adverse event types/frequency of YTS109 cell therapy; to collect preliminary efficacy data (rates of complete or partial response); to characterize PK/PD (Cmax, AUC, Tmax) and biomarker changes (B‑cell counts, cytokines); and to explore the lymphodepletion regimen.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • YTS109 cell

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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);
  • 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.;
  • 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:
  • Meeting the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);
  • 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 Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with 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 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.;
  • 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 Cytoplasmic Antibody-Associated Vasculitis:
  • 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, and eosinophilic 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 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.
  • Relapsing and refractory Antiphospholipid Syndrome:
  • Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG/IgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing/refractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and/or tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).
  • Note: Meeting either criterion 3 or 4 is sufficient.
  • Relapsing and refractory Rheumatoid arthritis:
  • Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, with a history of RA ≥ 3 months; 2. Inadequate response to at least two conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and at least one biological agent targeting cytokines/signal transduction pathways (such as TNFα inhibitors, IL-6R antagonists, anti-CD20 monoclonal antibodies, etc.). (Note: Inadequate response to methotrexate or leflunomide, with stable treatment for ≥ 3 months prior to screening); 3. Moderate to severe active RA: swollen joint count (SJC) ≥ 6, tender joint count (TJC) ≥ 6; 4. Elevation of at least one inflammatory marker: erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ upper limit of normal (ULN).
  • Relapsing and refractory IgG4-Related Disease:
  • 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:
  • Refractory: Defined as a lack of response to steroid therapy or steroid plus immunosuppressive therapy (no clinical or radiological improvement, with a decrease in RI < 2); 2) Relapse: Defined as new progression or recurrence of clinical symptoms or radiological manifestations in patients who have previously achieved remission, with or without an elevation in serum IgG4 levels (an increase in RI ≥ 2).

Exclusion criteria

  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Background: Autoimmune diseases (AIDs) are a group of disorders in which the immune system mistakenly targets and attacks the body's own tissues, leading to tissue damage. Based on the sites of involvement, autoimmune diseases can be broadly classified into two categories: organ-specific autoimmune diseases, such as myasthenia gravis affecting the nervous system, type 1 diabetes mellitus involving the destruction of pancreatic islet cells, and autoimmune hepatitis targeting the liver; and systemic autoimmune diseases that affect multiple tissues and organs, reflecting an imbalance in the immune system, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome（SS）, and systemic sclerosis（SSc）. Recently, the therapeutic advancements have been made in the management of AIDs. However, particularly the patients with relapsed/refractory, continue to face significant unmet clinical needs. CAR-T cell therapy has emerged as one of the innovative therapeutic modalities for autoimmune diseases, characterized by its controllable safety profile and durable therapeutic efficacy, warranting further clinical exploration and investigation in the future. YTS109 cell is a universal allogeneic STAR-T cell therapy targeting CD19, designed to efficiently eliminate B cells in patients with AIDs and mitigate autoimmune responses. Design: This is a Single-Center, Single-Arm, prospective exploratory clinical trial designed to evaluate the safety profile, preliminary therapeutic efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of YTS109 cell therapy in patients with relapsed/refractory autoimmune diseases. Approximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This study was approved by the IRB of Chinese People's Liberation Army (PLA) General Hospital. (Approval Number: S2025-233-01), All participants provided written informed consent.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants who meet eligibility and give informed consent will receive a single infusion of YTS109 cells (1.5×10^6 cells/kg); a lymphodepletion regimen may be given beforehand (the record does not list its drugs/doses). Study visits include blood draws for pharmacokinetic and pharmacodynamic testing on day 0, days 4, 7, 10 and weekly visits in weeks 2–4, plus disease assessments and safety checks at 2, 4, 8, and 12 weeks and ongoing adverse‑event follow‑up (planned through 24 weeks and extended to 52 weeks). Screening and on‑study procedures will include organ‑function tests, infection screening, and pregnancy testing as required by the registry. Participants must follow contraception requirements and other protocol rules described above.

How the study is structured. Phase 1, single-center, single-arm, open-label interventional trial. Approximately 6–12 adults will receive one infusion of YTS109 cells (1.5×10^6 cells/kg) and undergo repeated safety and efficacy assessments and blood sampling for PK/PD at set time points, with observation lasting up to 24–52 weeks.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 19, 2025
Primary completion
May 19, 2026 (estimated)
Study completion
May 19, 2027 (estimated)
Target enrollment
12 participants (estimated)
Last updated on registry
Jul 14, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborators
  • The First Medical Center of Chinese PLA General Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
CrCl
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
glucocorticoids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
forced vital capacity
A breathing test that measures the total amount of air a person can blow out after a full breath in. It is often given as a percentage of what is expected for a person's age and size.
DLCO
A breathing test that measures how well the lungs pass oxygen from the air into the blood.
standard treatment
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Relapse
A condition that improved with treatment and has since returned or worsened.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
five half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
CAR-T
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
pharmacokinetic
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamic
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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