Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases (NCT07236801) | Clinical Trial Compass
RecruitingPhase 1
Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases
China18 participantsStarted 2025-11-13
Plain-language 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 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ranges from 18 to 65 years old (including threshold), regardless of gender.
✓. 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.
✓. Refractory Lupus Nephritis:
Exclusion criteria
✕. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: 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.
✕. 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).
✕. 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);