[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593776":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Excyte Biopharma Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"YK012","EXPERIMENTAL","Phase Ib: Participants will receive four different target doses of YK012 in dose escalation stage to evaluate its safety and tolerability. Participants will receive two to three different target doses of YK012 in dose expansion stage to further evaluate its safety, tolerability and effectiveness in reducing disease activity. Phase II: Participants will receive either placebo or one to two different doses of YK012. The specific doses will be determined based on prior clinical trial results.",[13],"Drug: YK012",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","YK012 is a bispecific antibody targeting CD19 and CD3.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Xiaofeng Zeng, Doctor of Medicine","CONTACT","+86 13501069845","xiaofeng.zeng@cstar.org.cn",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100593776","phase-1-study-of-yk012-in-moderate-to-severe-systemic-lupus-erythematosus-100593776",false,"NCT07010835","Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Moderate to Severe Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive) at screening, regardless of sex\n* Meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE diagnosis for at least 24 weeks at screening\n* Positive for anti-dsDNA antibody and\u002For antinuclear antibody (ANA) and\u002For anti-Smith antibody at screening, as determined using the local laboratory's reference ranges at the study site\n* Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7\n* Receiving stable background therapy at screening\n* Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures.\n\nExclusion Criteria:\n\n* Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components\n* Received any anti-CD19\u002FCD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior to enrollment\n* Received TNF inhibitors, interleukin receptor blockers, other small molecules or biologics within 3 months or 5 half-lives prior to enrollment\n* Received intravenous immunoglobulins or plasmapheresis within 3 months prior to enrollment\n* Used traditional Chinese medicines\u002Fherbal preparations for SLE treatment containing within 2 weeks prior to enrollment\n* Received live or attenuated vaccines within 1 month prior to enrollment\n* Has other autoimmune diseases, inflammatory joint diseases, or skin disorders (other than SLE) that may interfere with disease activity assessment\n* History of malignancy within 5 years before screening, except for cured cases with no recurrence for at least 5 years, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of breast, or papillary thyroid cancer\n* Clinically significant cardiovascular\u002Fcerebrovascular diseases within 6 months prior to screening\n* Presence of QTcF interval prolongation on electrocardiogram (ECG)\n* Presence of poorly controlled hypertension at screening\n* History of non-SLE conditions requiring oral\u002Fintravenous\u002Fintramuscular\u002Fsubcutaneous corticosteroid therapy (\\>2 weeks) within 6 months prior to enrollment\n* Active tuberculosis at screening or untreated latent tuberculosis\n* History of solid organ or bone marrow transplantation\n* Presence of active infections\n* Lupus nephritis requiring protocol-prohibited medications as assessed by the investigator\n* Uncontrolled lupus crisis within 8 weeks prior to screening\n* History of central nervous system (CNS) disorders\n* Presence of clinically unstable or uncontrolled medical conditions at screening\n* Presence of clinically significant abnormal laboratory test results\n* Presence of active viral infections (e.g., hepatitis B, hepatitis C, HIV, or active syphilis)\n* Had major surgery within 4 weeks prior to enrollment or planned during study;\n* Participation in other interventional clinical trials within 4 weeks prior to enrollment\n* Pregnant or lactating women, or individuals with pregnancy plans during the study and within a specified period after treatment who are unwilling to use effective contraception\n* Other conditions deemed by investigators to preclude study participation.","ALL","18 Years","75 Years",{"count":56,"type":57},189,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).",[64],"Systemic Lupus Erythematosus (SLE)","2026-02-04",{"date":67,"type":68},"2026-02-05","ACTUAL",{"date":70,"type":68},"2025-08-25",{"date":72,"type":57},"2028-12",{"name":5,"class":6},1]