[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636111":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":24,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":24,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":24,"overallStatus":28,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Base Therapeutics (Shanghai) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous NK521","EXPERIMENTAL","Intervention: NK521 Cell Injection Route: Intravenous infusion Dose: 1×10⁹, 3×10⁹, 6×10⁹ cells",[13],"Biological: NK521 Cell Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Intraperitoneal NK521","Intervention: NK521 Cell Injection Route: Intraperitoneal perfusion Dose: 1×10⁹, 3×10⁹, 6×10⁹ NK cells per administration Regimen: Once weekly, 3 weeks per cycle, for 2 consecutive cycles, plus investigator-selected systemic therapy",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","NK521 Cell Injection","Gene-edited natural killer (NK) cell product with knockout of TIGIT, NKG2A, and TGF-β, administered via intravenous infusion or intraperitoneal perfusion for the treatment of malignant ascites associated with advanced solid tumors.",[15,9],null,[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","010","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},"Li Ning","CONTACT","0316-5918495","Ifcancergep@163.com",{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100636111","early-phase-1-nk521-in-the-treatment-of-malignant-ascites-associated-with-advanced-solid-tumors-100636111",false,"NCT07561437","NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors","Inclusion Criteria:\n\n* Pathologically diagnosed with relapsed\u002Frefractory advanced solid tumors, including but not limited to liver cancer, gastric cancer, colorectal cancer, ovarian cancer, etc.\n* Complicated with malignant ascites with identifiable tumor cells in ascites. Patients with advanced solid tumors who have failed at least 2 lines of standard therapy.\n* At least one measurable lesion on CT or MRI per RECIST v1.1.\n* ECOG performance status 0-2.\n* Life expectancy ≥3 months.\n* All toxicities from prior antineoplastic therapy have resolved to Grade 1 (CTCAE v5.0) or baseline except alopecia and fatigue; subjects with long-term stable sequelae from prior therapy (e.g., platinum-induced neuropathy) are allowed.\n* Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all subjects must agree to use contraception from signing informed consent until 6 months after the last NK521 infusion.\n* Able to comply with the study protocol and follow-up procedures.\n* Voluntarily signed and provided written informed consent.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis.\n* History of other malignancies within the past 3 years.\n* Active, known or suspected autoimmune disease, excluding hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), or diseases not expected to relapse without external triggers.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or organ transplantation.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormality requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block); QTc interval \\>480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular\u002Fcerebrovascular events within 6 months before enrollment; NYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%; uncontrolled hypertension.\n* Received radical radiotherapy within 4 weeks before enrollment; received local palliative radiotherapy within 2 weeks before enrollment.\n\nNot fully recovered from major surgery or trauma within 2 weeks before enrollment.\n\n-Participated in another investigational drug trial and received investigational therapy or used an investigational device within 4 weeks before enrollment.\n\nReceived cellular antineoplastic therapy within 1 year before dosing; received other antineoplastic therapy outside this protocol within 4 weeks before dosing, including but not limited to chemotherapy, molecular targeted therapy, hormonal therapy, immunotherapy, biotherapy, or Chinese herbal patent medicine with antineoplastic indications.\n\n* Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor therapy within 2 weeks before enrollment.\n* Received systemic therapy with corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunomodulatory agents (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment. Inhaled or topical corticosteroids are allowed in subjects without active autoimmune disease.\n* Positive virology test for hepatitis B or hepatitis C at screening, meeting any of the following:\n\n  1. HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN);\n  2. HCV antibody positive.\n* Known hypersensitivity or intolerance to PD-1 monoclonal antibody.\n\nMeeting any of the following laboratory criteria:\n\n1. Hematology: Absolute neutrophil count \\\u003C1.5×10⁹\u002FL; platelet count \\\u003C75×10⁹\u002FL; hemoglobin \\\u003C90 g\u002FL.\n2. Hepatic function: ALT \\>3×ULN (≥5×ULN for liver metastasis); AST \\>3×ULN (≥5×ULN for liver metastasis); TBIL \\>1.5×ULN, or TBIL \\>2.5×ULN (3.0 mg\u002FdL) for subjects with Gilbert syndrome.\n3. Renal function: Serum creatinine \\>1.5×ULN or creatinine clearance \\\u003C50 mL\u002Fmin.\n\n   * Any uncertain factors affecting subject safety or compliance.\n   * Any other severe or uncontrolled medical disease, active infection, abnormal physical examination, abnormal laboratory test, altered mental status, or psychiatric disease that, in the investigator's opinion, increases subject risk or affects study results.","ALL","18 Years","75 Years",{"count":58,"type":59},18,"ESTIMATED","INTERVENTIONAL",[62],"EARLY_PHASE1","Study Population: Adult subjects aged 18-75 years with relapsed\u002Frefractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy.\n\nStudy Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each):\n\nGroup A (Intravenous infusion): For subjects with small-volume malignant ascites.\n\nGroup B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites.\n\nEach group will follow a conventional \"3+3\" dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles.\n\nPrimary Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally.\n\nSecondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).",[65],"Advanced Solid Tumors","2026-04-28",{"date":68,"type":69},"2026-05-01","ACTUAL",{"date":71,"type":69},"2026-03-09",{"date":73,"type":59},"2028-10",{"name":5,"class":6},1]