[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-unresectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-unresectable":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":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100633195","phase-1-biomarker-guided-dual-target-car-t-cells-for-advanced-solid-tumors-100633195",false,"NCT07523529","Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors","A Phase 1\u002F2, Open-Label, Biomarker-Guided Master Protocol Evaluating Autologous Dual-Target CAR-T Cells Selected From a Predefined Target Library in Adults With Advanced Solid Tumors","SELECT-2CAR","Inclusion Criteria:\n\n* Age 18-75 years at consent\n* Histologically or cytologically confirmed advanced unresectable, metastatic, or recurrent solid malignancy (including recurrent high-grade glioma for CNSspecific pairs) for which standard curative therapy does not exist, is not tolerated, or has failed.\n* At least one predefined dual-target pair qualifies on central biomarker review. Recommended working thresholds: primary antigen \\>= 2+ intensity in \\>= 50% of viable tumor cells (or pair-specific equivalent) AND secondary antigen detectable in \\>= 25% of viable tumor cells, with acceptable normal-tissue risk after pathology review\n* At least 1 measurable lesion by RECIST 1.1, or measurable \u002F evaluable disease by RANO for CNS cohorts.\n* ECOG performance status 0-1 (CNS cohort may allow Karnofsky \\>= 70 or ECOG 0-2 if justified).\n* Adequate organ function: ANC \\>= 1.0 x 10\\^9\u002FL, platelets \\>= 75 x 10\\^9\u002FL, hemoglobin \\>= 8 g\u002FdL, creatinine clearance \\>= 50 mL\u002Fmin, AST \u002F ALT \\\u003C= 3 x ULN (\\\u003C= 5 x ULN if liver involvement), total bilirubin \\\u003C= 1.5 x ULN unless Gilbert syndrome, LVEF \\>= 45%, oxygen saturation \\>= 92% on room air.\n* Recovered to Grade \\\u003C= 1 from acute toxicities of prior anticancer therapy (except alopecia, stable endocrinopathies, or other protocol-allowed residual toxicities).\n* Adequate venous access and ability to undergo leukapheresis; successful manufacture of a release-qualified autologous dual-target CAR-T product.\n* Life expectancy \\>= 12 weeks.\n* Negative pregnancy test for persons of childbearing potential and agreement to use highly effective contraception per protocol.\n* Ability to understand and sign informed consent and comply with study follow-up, including long-term gene-modified cell monitoring.\n\nExclusion Criteria:\n\n* No qualifying target pair after central review, or target pair considered unsafe because of unacceptable predicted ontarget \u002F off-tumor risk.\n* Prior gene-modified cellular therapy directed against the same target pair within 6 months, or persistent clinically significant toxicity from prior cell \u002F gene therapy.\n* Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection; active tuberculosis; uncontrolled HIV; active hepatitis B or C with detectable \u002F unsafe viral burden.\n* Need for systemic corticosteroids \\> 10 mg prednisone equivalent daily or other systemic immunosuppressive therapy within 7 days before lymphodepletion, unless specifically allowed for physiologic replacement or CNS edema management per cohort rules.\n* Active autoimmune disease requiring systemic immunosuppression within the past 2 years, except protocol-allowed stable conditions.\n* Clinically significant cardiovascular disease (for example uncontrolled arrhythmia, recent myocardial infarction, unstable angina, decompensated heart failure), severe pulmonary compromise, or other major comorbidity making cell therapy unsafe.\n* Active symptomatic CNS hemorrhage, uncontrolled seizures, or uncontrolled intracranial hypertension; leptomeningeal disease requiring urgent intervention unless explicitly allowed in a CNS-specific cohort.\n* Pregnancy or breastfeeding.\n* Concurrent second malignancy requiring active systemic treatment, except certain low-risk or definitively treated cancers allowed by protocol.\n* Any condition that, in the investigator's judgment, would interfere with safe participation, product manufacture, infusion, or interpretation of results.","ALL","18 Years","75 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a multicenter, open-label, Phase 1\u002F2 master protocol evaluating autologous dual-target CAR-T cell therapy in adults with advanced solid cancers. After central biomarker screening, each participant is assigned the best-matched dual-target construct from a predefined target-pair library. The trial is designed to test whether biomarkerguided dual targeting can improve tumor control, reduce antigenescape risk, and preserve safety in solid tumors.",[29,30],"Advanced Unresectable","Metastatic",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64],"antigen co-expression","B7-H3","bi-specific CAR-T","biomarkerguided","CD133","CD44","CD56","CD70","CLDN18.2","dual-target CAR-T","EGFR","EGFRvIII","GD2","gastric cancer","glioblastoma","GPC3","HER2","hepatocellular carcinoma","IL13Ralpha2","Mesothelin","MUC1","NKG2D","NSCLC","ovarian cancer","pancreatic cancer","PD-L1","prostate cancer","PSMA","solid tumors","tandem CAR-T","TRAIL-R2","triple-negative breast cancer","VEGFR1","RECRUITING","2026-04-05",{"date":68,"type":69},"2026-04-13","ACTUAL",{"date":71,"type":69},"2026-03-02",{"date":73,"type":22},"2028-03-17",{"name":75,"class":76},"Beijing Biotech","INDUSTRY"]