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Systemic Lupus Erythematosus (SLE)Phase 1NCT07236801

Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases

A Phase 1 study testing YTS109 cell in people with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis, run by China Immunotech (Beijing) Biotechnology Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
YTS109 cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesChina
Study dates
13 Nov 2025to 13 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
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  • 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.
  • 4. Voluntary participation with signed informed consent and compliance.
  • Specific inclusion criteria:
  • Relapsing and refractory systemic lupus erythematosus:
  • 1. 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.
  • Refractory SLE-Associated Immune Thrombocytopenia:
  • Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg/kg/day of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count <50 × 10⁹/L on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.
  • Relapsing and refractory Sjögren's syndrome:
  • 1. 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. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6; 3. Testing positive for anti-SSA/Ro antibodies; 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;
  • 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:
  • 1. 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); 2. Testing positive for myositis-specific antibodies; 3. 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); 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.; 5. 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:
  • 1. 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.
  • 2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).
  • 3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.
  • 4. 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:
  • 1. 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.

Who cannot join

  • 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;
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  • 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;
  • Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dongmei Zhou contact

15252002644

zdm@xzhmu.edu.cn

China2 sites, 2 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Dongmei Zhou, 15252002644, zdm@xzhmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Subjects With Relapsing/Refractory Autoimmune Diseases

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.

Being tested
YTS109 cell
Medical subject headings
Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome, Myositis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YTS109 cellDrug

    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.

Study groups in NCT07236801
Study groupRoleWhat they receive
YTS109 cellExperimentalNot described
Receives: Drug: YTS109 cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

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

    Measured: 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)

  1. Efficacy Evaluation in relapsed/refractory autoimmune diseases

    The proportion of subjects achieving complete response (CR), partial response (PR), or other responses at week 12.

    Measured: 2, 4, 8, 12 weeks, and the observation will continue until 24 to 52 weeks post-treatment.

  2. Maximum Plasma Concentration of YTS109 (Cmax)

    To evaluate the metabolic characteristics of YTS109

    Measured: 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.

  3. Area Under the Plasma Concentration-Time Curve (AUC) of YTS109

    To evaluate the metabolic characteristics of YTS109

    Measured: 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.

  4. Time to Reach Maximum Plasma Concentration (Tmax) of YTS109

    To evaluate the metabolic characteristics of YTS109

    Measured: 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.

  5. Cytokines Concentration Level Change

    Evaluate the Pharmacodynamic (PD) effects of YTS109 cells

    Measured: 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.

  6. The reconstitution of B cell in peripheral blood

    Changes in B cells quantification and phenotypic in peripheral blood

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start13 Nov 2025
  3. Primary completion13 Nov 2026 (estimated)
  4. Study completion13 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07236801
Sponsor's protocol ID
YTS109-009
Status last verified
Oct 2025
First submitted
15 Nov 2025
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YTS109 cell in people with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis, run by China Immunotech (Beijing) Biotechnology Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dongmei Zhou (15252002644, zdm@xzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07236801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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