[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632217":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":41,"centralContacts":42,"locations":48,"responsibleParty":68,"collaborators":41,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":41,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":51,"whyStopped":41,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Pleural Mesothelioma Cohort","EXPERIMENTAL","Participants with malignant pleural mesothelioma receive lymphodepleting chemotherapy followed by locoregional intrapleural infusion of the dual-target allogeneic CAR-NK product.",[13,14,15],"Biological: EB-MF-CAR-NK-01","Drug: Fludarabine","Drug: Cyclophosphamide",{"label":17,"type":10,"description":18,"interventionNames":19},"Peritoneal Mesothelioma Cohort","Participants with malignant peritoneal mesothelioma receive the same conditioning backbone and product platform, but the CAR-NK cells are delivered by locoregional intraperitoneal administration.",[13,14,15],[21,28,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","EB-MF-CAR-NK-01","Example investigational product: donor-derived allogeneic NK cells engineered to recognize both MSLN-positive tumor cells and FAPpositive stromal elements, manufactured under GMP",[17,9],[27],"Mesothelin\u002FFAP Dual-Target CAR-NK Cells",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Fludarabine","Lymphodepleting chemotherapy administered before CAR-NK infusion",[17,9],[34],"Flu",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Cyclophosphamide","Lymphodepleting chemotherapy administered before CAR-NK infusion.",[17,9],[40],"Cy",null,[43],{"name":44,"role":45,"phone":46,"phoneExt":41,"email":47},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":58,"coordinates":59},"Point",[60,61],114.0683,22.54554,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":66,"phoneExt":41,"email":67},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":69,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100632217","phase-1-dual-target-mslnfap-car-nk-cells-for-pleural-and-peritoneal-mesothelioma-100632217",false,"NCT07510815","Dual-Target MSLN\u002FFAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma","A Phase 1\u002F2, Open-Label, Nonrandomized, Biomarker-Guided Study of Locoregional Allogeneic Dual-Target Mesothelin (MSLN) \u002F Fibroblast Activation Protein (FAP) Chimeric Antigen Receptor Natural Killer Cells in Adults With Unresectable, Recurrent, or Refractory Pleural or Peritoneal Mesothelioma","DUAL-MESO-NK","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically confirmed malignant pleural mesothelioma or malignant peritoneal mesothelioma; unresectable, recurrent, metastatic, or refractory disease.\n* Prior receipt of at least one standard systemic regimen for mesothelioma, or documented ineligibility, intolerance, or refusal of standard therapy considered reasonable by the investigator.\n* Central biomarker confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma at protocol-defined thresholds.\n* At least one measurable or evaluable lesion by cohort-appropriate imaging criteria.\n* ECOG performance status 0 to 1.\n* Adequate bone marrow, renal, hepatic, coagulation, cardiac, and pulmonary function to undergo lymphodepletion and locoregional cell infusion.\n* Safe procedural access for intrapleural or intraperitoneal administration, as applicable.\n* Recovery to Grade 1 or better from prior anticancer therapy toxicities, except alopecia, stable neuropathy, or controlled endocrine replacement.\n* Life expectancy of at least 12 weeks.\n* Negative pregnancy test for participants of childbearing potential and agreement to use protocoldefined contraception.\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* Active or untreated CNS metastases, leptomeningeal disease, or uncontrolled seizures.\n* Uncontrolled bacterial, fungal, viral, or mycobacterial infection, including empyema, active pleural space infection, peritonitis, or uncontrolled HBV, HCV, or HIV infection.\n* Autoimmune disease requiring systemic immunosuppression within 14 days before lymphodepletion, or prednisone equivalent greater than 10 mg\u002Fday.\n* Clinically significant cardiovascular disease, uncontrolled arrhythmia, unstable angina, recent myocardial infarction, or other condition judged to increase infusion risk.\n* Severe interstitial lung disease, baseline oxygen requirement, or other pulmonary compromise making pleural therapy unsafe.\n* Bowel perforation risk, uncontrolled bowel obstruction, uncontrolled ascites, or any abdominal condition that makes intraperitoneal infusion unsafe in the peritoneal cohort.\n* Prior gene-modified cell therapy directed against MSLN or FAP within the protocol washout period, or active graft-versus-host disease after prior transplant.\n* Need for concurrent systemic anticancer therapy other than protocol-permitted supportive care.\n* Pregnancy or breastfeeding.\n* Any medical, psychiatric, social, or logistical condition that, in the investigator's judgment, could compromise safety, compliance, or interpretability of study results.","ALL","18 Years","75 Years",{"count":82,"type":83},36,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","This example study evaluates locoregional allogeneic dual-target mesothelin\u002FFAP CAR-NK cells in adults with unresectable, recurrent, or refractory pleural or peritoneal mesothelioma.\n\nEligible participants must have central confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma. The phase 1 portion defines the recommended phase 2 dose and schedule, and the phase 2 expansion explores preliminary antitumor activity, persistence, and biomarker response in pleural and peritoneal disease cohorts.",[90],"Malignant Pleural Mesotheliomas",[92,93,94,95,96,97,98,99],"Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","MSLN","FAP","Dual-Target CAR-NK","Locoregional Cell Therapy","Solid Tumor Immunotherapy","2026-03-31",{"date":102,"type":103},"2026-04-06","ACTUAL",{"date":105,"type":103},"2026-03-02",{"date":107,"type":83},"2028-04-17",{"name":5,"class":6},1]