[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552145":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":51,"centralContacts":55,"locations":61,"responsibleParty":140,"collaborators":33,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":33,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":33,"enrollmentInfo":151,"targetDuration":33,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":64,"whyStopped":33,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,14,17,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","27T51 monotherapy",[13],"Other: 27T51",{"label":15,"type":10,"description":11,"interventionNames":16},"Dose Expansion - Arm A",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"Dose Expansion - Arm B","27T51+Cemiplimab",[13,21],"Drug: Cemiplimab",{"label":23,"type":10,"description":24,"interventionNames":25},"Dose Expansion - Arm C","27T51+Cemiplimab+Bevacizumab",[13,21,26],"Drug: Bevacizumab",[28,34,42],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"OTHER","27T51","Intravenous (IV) infusion",[9,15,18,23],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Cemiplimab","IV infusion",[18,23],[40,41],"Libtayo","REGN2810",{"type":35,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Bevacizumab","IV Infusion",[23],[47,48,49,50],"Avastin","Mvasi","Vegzelma","Zirabe",[52],{"name":53,"affiliation":5,"role":54},"Clinical Trial Management","STUDY_DIRECTOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":33,"email":60},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[62,80,95,111,125],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Massachusetts General Hospital","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-71.05977,42.35843,{"lat":74,"lon":73},[77],{"name":78,"role":58,"phone":79,"phoneExt":33,"email":33},"Oladapo Yeku, MD, FACP","617-643-9354",{"facility":81,"status":64,"city":82,"state":83,"zip":84,"country":68,"countryCode":69,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"John Theurer Cancer Center Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":71,"coordinates":86},[87,88],-74.04347,40.88593,{"lat":88,"lon":87},[91],{"name":92,"role":58,"phone":93,"phoneExt":33,"email":94},"Oncology Clinical Research Referral Office","551-996-1777","OncologyResearchReferral@hmhn.org",{"facility":96,"status":64,"city":97,"state":98,"zip":99,"country":68,"countryCode":69,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Roswell Park Cancer Institute","Buffalo","New York","14203",{"type":71,"coordinates":101},[102,103],-78.87837,42.88645,{"lat":103,"lon":102},[106],{"name":107,"role":58,"phone":108,"phoneExt":109,"email":110},"Laura Ryan","716-845-3057","7298","Laura.Ryan@RoswellPark.org",{"facility":112,"status":64,"city":113,"state":114,"zip":115,"country":68,"countryCode":69,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232",{"type":71,"coordinates":117},[118,119],-79.99589,40.44062,{"lat":119,"lon":118},[122],{"name":33,"role":58,"phone":123,"phoneExt":33,"email":124},"878-261-6063","IDDCReferrals@upmc.edu",{"facility":126,"status":64,"city":127,"state":128,"zip":129,"country":68,"countryCode":69,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"LDS Hospital","Salt Lake City","Utah","84143",{"type":71,"coordinates":131},[132,133],-111.89105,40.76078,{"lat":133,"lon":132},[136],{"name":137,"role":58,"phone":138,"phoneExt":33,"email":139},"Joshua Kunz","801-408-4724","joshua.kunz@imail.org",{"type":141,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100552145","phase-1-a-study-to-learn-if-27t51-a-mucin-16-muc16-protein-targeting-immune-cell-therapy-administered-alone-or-in-combination-is-safe-and-how-well-it-works-for-adult-participants-with-recurrent-or-treatment-resistant-ovarian-cancers-100552145",false,"NCT06469281","A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers","A Phase 1a\u002F1b Study of 27T51, an Anti-MUC16 CAR T Cell Drug Product Administered Alone or in Combination for Participants With Recurrent or Refractory Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n2. Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification\n3. Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol\n4. Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening\n5. Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.\n6. Expected survival ≥ 3 months\n\nKey Exclusion Criteria:\n\n1. Inadequate cardiovascular, renal and hepatic function, as described in the protocol\n2. Absolute lymphocyte count (ALC) \\\u003C 100 cells\u002FμL at time of leukapheresis\n3. History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol\n4. Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol\n5. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)\n6. Treatment with any cellular or gene therapy\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply","FEMALE","18 Years",{"count":152,"type":153},90,"ESTIMATED","INTERVENTIONAL",[156],"PHASE1","This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer.\n\nThis study has two (2) major parts:\n\nPhase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51.\n\nInformation collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.",[159,160,161],"Epithelial Ovarian Cancer","Primary Peritoneal Carcinoma","Fallopian Tube Cancer",[163,164,165,166,167,168],"Ovarian Cancer","CAR T","Peritoneal","Fallopian Tube","MUC16","Immunotherapy","2026-01-30",{"date":171,"type":172},"2026-02-03","ACTUAL",{"date":174,"type":172},"2024-08-06",{"date":176,"type":153},"2030-05-27",{"name":5,"class":6},5]