[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psca-positive-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psca-positive-prostate-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"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":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Metastatic Castration-resistant Prostate Cancer","Advanced Prostate Adenocarcinoma","PSCA-positive Prostate Cancer","PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer",[32,33,34,35,36,37,38,39,40,41],"CAR-NK","dual-target","PSMA","PSCA","mCRPC","metastatic prostate cancer","cell therapy","immunotherapy","dose escalation","dose expansion","RECRUITING","2026-06-06",{"date":45,"type":46},"2026-06-11","ACTUAL",{"date":48,"type":46},"2026-03-02",{"date":50,"type":21},"2028-06-17",{"name":52,"class":53},"Beijing Biotech","INDUSTRY"]