[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer---recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer---recurrent":33},{"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":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":42,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":5},"100624504","phase-1-biomarker-guided-allogeneic-single-target-or-dual-target-car-nk-cell-therapy-for-advanced-solid-tumors-100624504",false,"NCT07410494","Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors","A Phase 1\u002F2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and\u002For Liquid Biopsy Profiling in Participants With Relapsed\u002FRefractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)","SELECT-CAR-NK","Inclusion Criteria:\n\n* Age 18-75 years.\n* Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumor that is relapsed\u002Frefractory after standard therapy, or no standard therapy available.\n* Targetable antigen positivity from the protocol target menu based on:\n\ntissue biopsy and\u002For liquid biopsy platform (as defined in the lab manual).\n\n* Arm assignment rules :\n* Arm A: ≥1 antigen meets \"positive\" threshold\n* Arm B: ≥2 antigens meet \"positive\" threshold\n* ECOG performance status 0-1 (or 0-2 ).\n* At least one measurable lesion by RECIST 1.1.\n* Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.\n* Willingness to undergo blood draws and required biopsies (when medically feasible).\n* Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.\n\nExclusion Criteria:\n\n* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .\n* Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV\u002FHCV with detectable viral load (per local policy).\n* Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).\n* Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.\n* Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.\n* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).\n* Pregnant or breastfeeding.","ALL","8 Years","85 Years",{"count":21,"type":22},85,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This Phase 1\u002F2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and\u002For liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.",[29,30,31,32,33,34,35,36,37,38,39,40,41],"Cancer","Breast Cancer","Non-Small Cell Lung Cancer (NSCLC)","Colorectal Cancer (Locally Advanced or Metastatic)","Prostate Cancer - Recurrent","Pancreatic Ductal Adenocarcinoma (PDAC)","Ovarian Cancer","Glioblastoma","Melanoma (Skin Cancer)","Acute Myeloid Leukemia (AML)","Non Hodgkin Lymphoma","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Liver Cancer",[43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"CAR-NK","Solid tumor","Dual-target CAR","ctDNA","CAR-T","Breast cancer","Non-small cell lung cancer (NSCLC)","Colorectal cancer (CRC)","Prostate cancer","Pancreatic ductal adenocarcinoma (PDAC)","Ovarian, fallopian tube, and primary peritoneal cancers","Glioblastoma and other high-grade gliomas","Melanoma","Acute myeloid leukemia (AML)","Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphoma","Multiple myeloma (especially relapsed\u002Frefractory)","Liver cancer (hepatocellular carcinoma, HCC)","RECRUITING","2026-02-14",{"date":63,"type":64},"2026-02-18","ACTUAL",{"date":66,"type":64},"2026-02-01",{"date":68,"type":22},"2028-12-28",{"name":70,"class":71},"Essen Biotech","OTHER"]