[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626443":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":30,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":30,"enrollmentInfo":68,"targetDuration":30,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SK-NK Cell Injection","EXPERIMENTAL","Participants receive SK-NK Cell Injection via intraperitoneal perfusion. Phase I follows a \"3+3\" dose-escalation design with three cohorts (3\\*10\\^8, 6\\*10\\^8, and 9\\*10\\^8 cells). Phase II operates at the Recommended Phase 2 Dose (RP2D). Treatment is administered once weekly for 4 weeks (Days 1, 8, 15, and 22).",[13],"Biological: SK-NK Cell Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Administered via intraperitoneal perfusion. Phase I involves a \"3+3\" dose escalation with three cohorts: 3x10\\^8, 6x10\\^8, and 9x10\\^8 cells. Phase II uses the Recommended Phase 2 Dose (RP2D). The treatment schedule consists of one infusion weekly for 4 weeks (Days 1, 8, 15, and 22). The product is characterized by high purity (\\>99%) and high expression of activation markers.",[9],[20,21],"Super Kill-NK Cell Injection","Allogeneic NK Cell Injection",[23],{"name":24,"affiliation":5,"role":25},"Ning Li, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","8610-87787211",null,"liningnci@126.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48,51],{"name":24,"role":28,"phone":49,"phoneExt":30,"email":50},"8610-87787210","cancergcp@163.com",{"name":24,"role":25,"phone":30,"phoneExt":30,"email":30},{"type":25,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"NING LI-GYN","Chief Physician",[56],{"name":57,"class":58},"Cells First Biotechnology (Beijing) Co., Ltd","UNKNOWN","100626443","phase-1-intraperitoneal-sk-nk-cell-injection-for-advanced-ovarian-cancer-with-massive-ascites-100626443",false,"NCT07435701","Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites","A Single-Arm, Open-Label Phase I\u002FII Clinical Trial of Intraperitoneal Perfusion of SK-NK Cell Injection for the Treatment of Advanced Ovarian Cancer Patients With Massive Ascites","Inclusion Criteria:\n\nVoluntarily sign the written Informed Consent Form (ICF) and be able to comply with study procedures and follow-up.\n\nFemale, aged 18 to 75 years. ECOG performance status of 0 to 2. Histologically or cytologically confirmed advanced ovarian cancer. Participants must have failed at least two lines of standard therapy (disease progression or intolerance), have no standard therapy available, or be unable to receive standard therapy for other reasons .\n\nComplicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT.\n\nExpected survival time ≥ 3 months.\n\nAdequate organ function (no blood transfusion, cell growth factors, etc., within 14 days prior to enrollment), defined as:\n\nNeutrophils (ANC) ≥ 1.0×10\\^9\u002FL Platelets (PLT) ≥ 80×10\\^9\u002FL Hemoglobin (Hb) ≥ 80 g\u002FL Total Bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome or liver metastasis) ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis is present) INR ≤ 1.5×ULN and APTT ≤ 1.5×ULN (unless on anticoagulant therapy) Creatinine clearance ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) Toxicities from prior therapies must have recovered to ≤ Grade 1 (except for alopecia and ≤ Grade 2 neurotoxicity caused by chemotherapy) .\n\nExclusion Criteria:\n\nPrior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor therapy (including chemotherapy, targeted therapy, etc.) within 3 weeks prior to intraperitoneal perfusion.\n\nReceipt of Traditional Chinese Medicine (herbal) with anti-tumor indications within 3 weeks prior to intraperitoneal perfusion.\n\nReceipt of systemic corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 2 weeks prior to intraperitoneal perfusion (inhaled, topical, or physiologic replacement doses are allowed).\n\nMajor surgery within 4 weeks prior to screening or planned major surgery during the study period.\n\nHistory of other malignancies within 5 years (except for cured local tumors with low risk of recurrence, such as non-melanoma skin cancer).\n\nHistory of active or suspected autoimmune or inflammatory disease. History of organ transplantation or hematopoietic stem cell transplantation.\n\nPresence of active infection, including:\n\nActive Hepatitis B (HBsAg positive and HBV-DNA \\> 1000 copies\u002FmL) Active Hepatitis C (HCV antibody positive and HCV-RNA detected) Systemic active infection requiring antibiotic treatment Congenital or acquired immunodeficiency (e.g., HIV infection) Vaccination with live or attenuated vaccines within 4 weeks prior to intraperitoneal perfusion.\n\nSevere cardiovascular diseases, including:\n\nUncontrolled hypertension (SBP \\> 160 mmHg and\u002For DBP \\> 100 mmHg) History of hypertensive crisis or hypertensive encephalopathy Cardiovascular accident, TIA, myocardial infarction, unstable angina, or significant vascular disease within 6 months NYHA Class ≥ II heart failure or LVEF \\\u003C 50% Severe arrhythmia uncontrolled by medication (QTc ≥ 450 ms for males, ≥ 470 ms for females), or congenital Long QT syndrome Severe respiratory disease (e.g., history of severe interstitial lung disease, severe COPD), FEV1 \\\u003C 2L, or DLCO \\\u003C 40%.\n\nHistory of clear neurological or psychiatric disorders, including epilepsy or dementia.\n\nOther conditions considered unsuitable for the study by the investigator (e.g., prior Grade ≥ 3 adverse events from immunotherapy).","FEMALE","18 Years",{"count":69,"type":70},29,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","This is a single-center, open-label, Phase I\u002FII clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites .\n\nThe study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity .\n\nThe study consists of two phases:\n\nPhase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a \"3+3\" design with three increasing dose levels.\n\nPhase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D.\n\nParticipants will receive the study treatment once weekly for 4 weeks.",[77,78],"Ovarian Neoplasms Malignant","Ascites",[9,80,81,82,83,84,85],"Natural Killer Cells","NK Cell Therapy","Intraperitoneal Perfusion","Adoptive Immunotherapy","Immunotherapy","Massive Ascites","2026-03-13",{"date":88,"type":89},"2026-03-17","ACTUAL",{"date":91,"type":89},"2026-01-05",{"date":93,"type":70},"2026-12-31",{"name":5,"class":6},1]