[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643460":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":41,"enrollmentInfo":80,"targetDuration":41,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":51,"whyStopped":41,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Participants receive fludarabine\u002Fcyclophosphamide lymphodepletion followed by a single IV infusion of ETB-DualNK-01 at escalating dose levels. Safety during the Day 28 DLT window determines escalation.",[13,14,15],"Biological: ETB-DualNK-01","Drug: Fludarabine","Drug: Cyclophosphamide",{"label":17,"type":10,"description":18,"interventionNames":19},"Dose Expansion","Participants receive ETB-DualNK-01 at the selected RP2D after the same lymphodepletion regimen. One optional repeat infusion may be permitted if predefined safety criteria are met.",[13,14,15],[21,28,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","ETB-DualNK-01","Allogeneic dual-target antiPSMA\u002FPSCA CAR-NK cells administered intravenously on Day 0; repeat infusion permitted only per protocol in Part B.",[9,17],[27],"Dual-target anti-PSMA\u002FPSCA CAR-NK cells",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Fludarabine","Lymphodepletion regimen: 30 mg\u002Fm2\u002Fday IV on Days -5 to -3 before ETB-DualNK-01 infusion.",[9,17],[34],"Fludara",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Cyclophosphamide","Lymphodepletion regimen: 300 mg\u002Fm2\u002Fday IV on Days -5 to -3 before ETB-DualNK-01 infusion",[9,17],[40],"Cytoxan",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","100643460","phase-1-dual-target-psmapsca-car-nk-cells-in-advanced-prostate-cancer-100643460",false,"NCT07641049","Dual-target PSMA\u002FPSCA CAR-NK Cells in Advanced Prostate Cancer","A Phase 1, Open-Label, Multicenter, Dose-Escalation and Dose-Expansion Study of ETB-DualNK-01, an Allogeneic Dual-target PSMA\u002FPSCA CAR-NK Cell Product, in Adults With Metastatic Castration-Resistant Prostate Cancer","DUAL-NK-PC","Inclusion Criteria:\n\n* Male participant age 18 years or older.\n* Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant disease.\n* Disease progression by PCWG3 while maintaining castrate testosterone (\\\u003C50 ng\u002FdL) with ongoing androgen deprivation therapy or prior orchiectomy.\n* Documented PSMA and\u002For PSCA expression by a validated tumor assay; PSMA PET may support target confirmation when applicable.\n* Prior progression on at least one androgen receptor pathway inhibitor such as abiraterone, enzalutamide, apalutamide, or darolutamide; prior taxane, PARP inhibitor, radioligand therapy, or checkpoint inhibitor is allowed.\n* ECOG performance status 0 or 1.\n* Adequate hematologic, renal, hepatic, cardiac, and pulmonary function per protocol laboratory thresholds.\n* At least one measurable lesion by RECIST 1.1 or evaluable bone-predominant disease by PCWG3.\n* Life expectancy of at least 12 weeks.\n* Ability to understand and sign informed consent and willingness to provide required blood and tissue samples.\n\nExclusion Criteria:\n\n* Active central nervous system metastases or leptomeningeal disease.\n* Dominant small-cell or neuroendocrine prostate cancer histology.\n* Prior gene-modified cellular therapy within 6 months before lymphodepletion, or prior allogeneic transplant requiring ongoing systemic immunosuppression.\n* Active autoimmune disease requiring systemic treatment or chronic immunosuppression; systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days of lymphodepletion.\n* Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.\n* Clinically significant cardiovascular disease, symptomatic arrhythmia, recent myocardial infarction, or uncontrolled heart failure.\n* Unresolved grade 2 or higher toxicity from prior anticancer therapy, except alopecia, stable endocrinopathy, or other protocol-approved exceptions.\n* Another active malignancy requiring systemic treatment.\n* Any medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, would increase risk or interfere with study interpretation.","MALE","18 Years",{"count":81,"type":82},36,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA\u002FPSCA CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC). Part A uses dose escalation to determine the maximum tolerated dose and\u002For recommended Phase 2 dose. Part B expands at the selected dose in biomarkerconfirmed disease.",[88,89,90,91],"Metastatic Castration-resistant Prostate Cancer","Advanced Prostate Adenocarcinoma","PSCA-positive Prostate Cancer","PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer",[93,94,95,96,97,98,99,100,101,102],"CAR-NK","dual-target","PSMA","PSCA","mCRPC","metastatic prostate cancer","cell therapy","immunotherapy","dose escalation","dose expansion","2026-06-06",{"date":105,"type":106},"2026-06-11","ACTUAL",{"date":108,"type":106},"2026-03-02",{"date":110,"type":82},"2028-06-17",{"name":5,"class":6},1]