[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633195":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":22,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":22,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":44,"whyStopped":22,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biomarker-guided dual-target CAR-T therapy","EXPERIMENTAL","Participants undergo central antigen-pair screening and receive the bestmatched autologous dual-target CAR-T construct from the predefined library after lymphodepletion with fludarabine \u002F cyclophosphamide. A second infusion may be permitted in selected participants if product is available, the assigned dose level remains safe, and retreatment criteria are met.",[13,14,15],"Biological: Autologous dual-target CAR-T cells selected from the predefined target library.","Drug: Fludarabine","Drug: Cyclophosphamide",[17,23,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","Autologous dual-target CAR-T cells selected from the predefined target library.","Autologous dual-target CAR-T cells are patient-derived T cells engineered to recognize two tumor-associated antigens selected from a predefined target library. In clinical trials, they are administered to enhance tumor targeting and reduce antigen escape, with evaluation of safety, tolerability, and preliminary anti-tumor activity.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Fludarabine","chemotherapy preconditioning regimen used before cell therapy to reduce the patient's existing lymphocytes and create space for infused cells. In clinical trials, it is given prior to CAR-T infusion to enhance cell expansion, persistence, and overall treatment efficacy.",[9],[29],"lymphodepletion",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Cyclophosphamide","Cyclophosphamide lymphodepletion is a chemotherapy preconditioning regimen administered prior to cell therapy to suppress existing immune cells and improve the environment for infused cells. In clinical trials, it is given before CAR-T infusion to support cell expansion, persistence, and enhance therapeutic effectiveness.",[9],[29],[36],{"name":37,"role":38,"phone":39,"phoneExt":22,"email":40},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.0683,22.54554,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":22,"email":60},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":62,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","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":75,"type":76},72,"ESTIMATED","INTERVENTIONAL",[79,80],"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.",[83,84],"Advanced Unresectable","Metastatic",[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"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","2026-04-05",{"date":121,"type":122},"2026-04-13","ACTUAL",{"date":124,"type":122},"2026-03-02",{"date":126,"type":76},"2028-03-17",{"name":5,"class":6},1]