[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599350":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":23,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":20,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":20,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":46,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":20},{"fullName":5,"class":6},"Base Therapeutics (Shanghai) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NK510 infusion","EXPERIMENTAL","NK510",[13],"Drug: NK510 : allogeneic genetic modified NK",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","NK510 : allogeneic genetic modified NK","NK510 is an allogeneic genetic modification of NK cell. NK510 will be administered at a dose of 4x10\\^7 NK\u002Fkg, 8x10\\^7 NK\u002Fkg and 1.2x10\\^8 NK\u002Fkg by a dose-escalation design and administered IV.",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[24],{"name":25,"class":26},"The First Affiliated Hospital of Anhui Medical University","OTHER","100599350","nk510-cell-therapy-for-refractory-systemic-lupus-erythematosus-100599350",false,"NCT07083349","NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus","An Open, Single-Center Exploratory Clinical Study of NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* 18 to 70 years old, male or female.\n* A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)\u002FACR (American College of Rheumatology).\n* The subject voluntarily participates in this clinical study and signs the Informed Consent Form (ICF).\n* Before screening, the subject must have received glucocorticoid combined with immunosuppressants and\u002For biological agents for at least 2 months, with a stable dose for more than 2 weeks, but the disease remains active; within 7 days before lymphodepleting conditioning, the blood routine test must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; hemoglobin (Hb) ≥ 80g\u002FL; platelet count (PLT) ≥ 50×10⁹\u002FL.\n* SLEDAI-2K score \\> 8 points at screening.\n* Antinuclear antibody (ANA) ≥ 1:80 at screening.\n* Having appropriate organ functions:\n\n  1. Liver function: aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN, unless the subject has a record of Gilbert syndrome; subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN can be included;\n  2. Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL\u002Fmin;\n  3. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; absolute lymphocyte count (ALC) ≥ 0.1×10⁹\u002FL; hemoglobin (Hb) ≥ 80 g\u002FL; platelet count (PLT) ≥ 50×10⁹\u002FL.\n* Women of childbearing age must be non-lactating and have a negative serum pregnancy test within 1 week before administration. In addition, all subjects (whether male or female) must agree to use contraception during the period of NK510 treatment starting from enrollment and within 3 months after the end of treatment.\n* Able to comply with the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\n* Patients with active lupus nephritis.\n* Those with allergies to the study drug or other medications used in the study protocol.\n* Those with any of the following conditions: ① Having received autologous\u002Fallogeneic hematopoietic stem cell transplantation within 3 months; ② Having received ultraviolet irradiation therapy within 6 weeks; ③ Having received biologic agent therapy (excluding other medications used in the study protocol) within 4 weeks or 3 half-lives (whichever is longer); ④ Having undergone major surgery or received live vaccines within 4 weeks; ⑤ Having received experimental treatment (except for definite placebo control groups) within 4 weeks.\n* Those with other active, known, or suspected autoimmune diseases.\n* Presence of uncontrolled active bacterial, viral, fungal, mycobacterial, or other infections requiring treatment with intravenous antibiotics, antiviral drugs, or antifungal drugs within 14 days before lymphodepleting conditioning; however, prophylactic use of these drugs (including intravenous administration) is allowed.\n* History of immunodeficiency, including positive HIV test results, or other acquired\u002Fcongenital immunodeficiency diseases, or history of organ transplantation.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); QTc interval \\> 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before administration; New York Heart Association (NYHA) cardiac function class ≥ II or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Failure to fully recover from major surgery or trauma within 2 weeks before administration.\n* History of malignant tumors.\n* Screening results of hepatitis B or C virological tests meeting any of the following:\n\n  1. HBsAg positive, and peripheral blood HBV-DNA titer ≥ 1×10³ copies\u002FmL or upper limit of normal;\n  2. Anti-HCV positive.\n* Those deemed unsuitable for participation in the study by the investigator.","ALL","18 Years","70 Years",{"count":38,"type":39},9,"ESTIMATED","INTERVENTIONAL",[42],"NA","This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.",[45],"Refractory Systemic Lupus Erythematosus",[47],"SLE","NOT_YET_RECRUITING","2025-07-23",{"date":51,"type":52},"2025-07-28","ACTUAL",{"date":54,"type":39},"2025-08-01",{"date":56,"type":39},"2027-09-01",{"name":5,"class":6}]