[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636339":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":33,"responsibleParty":98,"collaborators":24,"id":100,"slug":24,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":24,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":24,"enrollmentInfo":108,"targetDuration":24,"studyType":111,"phases":112,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":36,"whyStopped":24,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I","EXPERIMENTAL","Dose escalation with DJI136",[13],"Drug: DJI136",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase II","Treatment at the recommended dose(s) of DJI136 as identified in Phase I.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","DJI136","DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Novartis Pharmaceuticals","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":27,"role":28,"phone":32,"phoneExt":24,"email":24},"+41613241111",[34,55,72,89],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of Kentucky","RECRUITING","Lexington","Kentucky","40536","United States",{"type":42,"coordinates":43},"Point",[44,45],-84.47772,37.98869,{"lat":45,"lon":44},[48,52],{"name":49,"role":28,"phone":50,"phoneExt":24,"email":51},"Jamie Tarr","859-218-5151","Jamie.Tarr@uky.edu",{"name":53,"role":54,"phone":24,"phoneExt":24,"email":24},"Zhonglin Hao","PRINCIPAL_INVESTIGATOR",{"facility":56,"status":36,"city":57,"state":58,"zip":59,"country":40,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":42,"coordinates":61},[62,63],-95.36327,29.76328,{"lat":63,"lon":62},[66,70],{"name":67,"role":28,"phone":68,"phoneExt":24,"email":69},"Zheng Zhang","713-792-0007","Zzhang11@mdanderson.org",{"name":71,"role":54,"phone":24,"phoneExt":24,"email":24},"Bingnan Zhang",{"facility":73,"status":36,"city":74,"state":75,"zip":76,"country":40,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":42,"coordinates":78},[79,80],-122.33207,47.60621,{"lat":80,"lon":79},[83,87],{"name":84,"role":28,"phone":85,"phoneExt":24,"email":86},"David Qian","206-288-6938","dqian@fredhutch.org",{"name":88,"role":54,"phone":24,"phoneExt":24,"email":24},"Diane Tseng",{"facility":90,"status":36,"city":91,"state":24,"zip":92,"country":91,"cosmosGeoPoint":93,"geoPoint":97,"contacts":24},"Novartis Investigative Site","Singapore","168583",{"type":42,"coordinates":94},[95,96],103.85007,1.28967,{"lat":96,"lon":95},{"type":99,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100636339",false,"NCT07564401","A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy","A Phase I\u002FII Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC","Inclusion Criteria:\n\n* Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, according to the investigator's judgement. Prior DLL3 (Delta-like ligand 3) targeted therapy is allowed.\n* Phase II: Patients with ES-SCLC who have received a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor according to local standard of care, unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, as determined by the investigator's judgment. Prior DLL-3 targeted therapy is not allowed.\n* Male or female patients must be ≥ 18 years of age.\n* Histologically or cytologically confirmed small cell lung cancer (SCLC).\n* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Patients must have an archival tumor tissue available, collected within 6 months prior to screening. If an archival tumor sample, collected within 6 months prior to screening, is not available, patients must be willing to undergo a new tumor biopsy at screening; , however this specimen need not be collected prior to scheduling leukapheresis. If a new biopsy is not medically feasible, exceptions may be considered after documented discussion with the Novartis medical monitor.\n* Patient must be deemed suitable by the investigator to undergo the lymphodepletion (LD) regimen.\n* Patient must have an apheresis product of non-mobilized cells accepted for manufacturing.\n\nExclusion Criteria:\n\n* Prior administration of a genetically modified cellular product, including prior DLL3-targeted CAR-T cell therapy.\n* Unstable or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria.\n* Uncontrolled seizure disorder.\n* Clinically significant active infections, including Hepatitis B\u002FC and Human Immunodeficiency Virus (HIV).\n* Has a known additional malignancy that is progressing or requires active treatment, with specific exceptions as defined in the study protocol.\n* History of prior solid organ transplant or allogenic hematopoietic cell transplant\n* Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol.\n* Pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":109,"type":110},80,"ESTIMATED","INTERVENTIONAL",[113,114],"PHASE1","PHASE2","This is a Phase I\u002FII, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.",[117],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)",[119,120,121,122,123,124,125,21],"Small cell lung cancer","SCLC","Extensive-stage small cell lung cancer","ES-SCLC","Chimeric antigen receptor (CAR)-T cell therapy","Delta-like ligand 3","DLL3","2026-06-22",{"date":128,"type":129},"2026-06-23","ACTUAL",{"date":131,"type":129},"2026-06-16",{"date":133,"type":110},"2031-03-03",{"name":27,"class":6},4]