[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054097":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":24,"locations":30,"responsibleParty":192,"collaborators":20,"id":194,"slug":20,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":20,"eligibilityCriteria":199,"healthyVolunteers":195,"sex":200,"minAge":201,"maxAge":20,"enrollmentInfo":202,"targetDuration":20,"studyType":205,"phases":206,"briefSummary":208,"conditions":209,"keywords":218,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NT-175 for advanced malignancies","EXPERIMENTAL","TCR T cell therapy product",[13],"Biological: NT-175",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","NT-175","* Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide\n* Single infusion Autologous, engineered T Cells targeting TP53 R175H\n* Post-infusion recombinant interleukin-2 (rIL-2)",[9],null,[22],{"name":5,"affiliation":5,"role":23},"STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":20,"email":29},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[31,45,54,62,70,79,88,96,105,114,122,131,139,148,157,166,175,183],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"Research Site","RECRUITING","Gilbert","Arizona","85234","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-111.78903,33.35283,{"lat":43,"lon":42},{"facility":32,"status":33,"city":46,"state":47,"zip":48,"country":37,"countryCode":38,"cosmosGeoPoint":49,"geoPoint":53,"contacts":20},"Duarte","California","91010",{"type":40,"coordinates":50},[51,52],-117.97729,34.13945,{"lat":52,"lon":51},{"facility":32,"status":33,"city":55,"state":47,"zip":56,"country":37,"countryCode":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":20},"Newport Beach","92663",{"type":40,"coordinates":58},[59,60],-117.92895,33.61891,{"lat":60,"lon":59},{"facility":32,"status":33,"city":63,"state":47,"zip":64,"country":37,"countryCode":38,"cosmosGeoPoint":65,"geoPoint":69,"contacts":20},"Santa Monica","90404",{"type":40,"coordinates":66},[67,68],-118.49138,34.01949,{"lat":68,"lon":67},{"facility":32,"status":33,"city":71,"state":72,"zip":73,"country":37,"countryCode":38,"cosmosGeoPoint":74,"geoPoint":78,"contacts":20},"Jacksonville","Florida","32224",{"type":40,"coordinates":75},[76,77],-81.65565,30.33218,{"lat":77,"lon":76},{"facility":32,"status":80,"city":81,"state":72,"zip":82,"country":37,"countryCode":38,"cosmosGeoPoint":83,"geoPoint":87,"contacts":20},"WITHDRAWN","Miami","33136",{"type":40,"coordinates":84},[85,86],-80.19366,25.77427,{"lat":86,"lon":85},{"facility":32,"status":80,"city":89,"state":72,"zip":90,"country":37,"countryCode":38,"cosmosGeoPoint":91,"geoPoint":95,"contacts":20},"Tampa","33612",{"type":40,"coordinates":92},[93,94],-82.45843,27.94752,{"lat":94,"lon":93},{"facility":32,"status":33,"city":97,"state":98,"zip":99,"country":37,"countryCode":38,"cosmosGeoPoint":100,"geoPoint":104,"contacts":20},"Boston","Massachusetts","02115",{"type":40,"coordinates":101},[102,103],-71.05977,42.35843,{"lat":103,"lon":102},{"facility":32,"status":33,"city":106,"state":107,"zip":108,"country":37,"countryCode":38,"cosmosGeoPoint":109,"geoPoint":113,"contacts":20},"New Brunswick","New Jersey","08901",{"type":40,"coordinates":110},[111,112],-74.45182,40.48622,{"lat":112,"lon":111},{"facility":32,"status":33,"city":115,"state":115,"zip":116,"country":37,"countryCode":38,"cosmosGeoPoint":117,"geoPoint":121,"contacts":20},"New York","10065",{"type":40,"coordinates":118},[119,120],-74.00597,40.71427,{"lat":120,"lon":119},{"facility":32,"status":80,"city":123,"state":124,"zip":125,"country":37,"countryCode":38,"cosmosGeoPoint":126,"geoPoint":130,"contacts":20},"Charlotte","North Carolina","28204",{"type":40,"coordinates":127},[128,129],-80.84313,35.22709,{"lat":129,"lon":128},{"facility":32,"status":80,"city":132,"state":124,"zip":133,"country":37,"countryCode":38,"cosmosGeoPoint":134,"geoPoint":138,"contacts":20},"Winston-Salem","27103",{"type":40,"coordinates":135},[136,137],-80.24422,36.09986,{"lat":137,"lon":136},{"facility":32,"status":33,"city":140,"state":141,"zip":142,"country":37,"countryCode":38,"cosmosGeoPoint":143,"geoPoint":147,"contacts":20},"Portland","Oregon","97213",{"type":40,"coordinates":144},[145,146],-122.67621,45.52345,{"lat":146,"lon":145},{"facility":32,"status":33,"city":149,"state":150,"zip":151,"country":37,"countryCode":38,"cosmosGeoPoint":152,"geoPoint":156,"contacts":20},"Pittsburgh","Pennsylvania","15232",{"type":40,"coordinates":153},[154,155],-79.99589,40.44062,{"lat":155,"lon":154},{"facility":32,"status":33,"city":158,"state":159,"zip":160,"country":37,"countryCode":38,"cosmosGeoPoint":161,"geoPoint":165,"contacts":20},"Nashville","Tennessee","37203",{"type":40,"coordinates":162},[163,164],-86.78444,36.16589,{"lat":164,"lon":163},{"facility":32,"status":33,"city":167,"state":168,"zip":169,"country":37,"countryCode":38,"cosmosGeoPoint":170,"geoPoint":174,"contacts":20},"Houston","Texas","77030",{"type":40,"coordinates":171},[172,173],-95.36327,29.76328,{"lat":173,"lon":172},{"facility":32,"status":33,"city":176,"state":168,"zip":177,"country":37,"countryCode":38,"cosmosGeoPoint":178,"geoPoint":182,"contacts":20},"Round Rock","78665",{"type":40,"coordinates":179},[180,181],-97.6789,30.50826,{"lat":181,"lon":180},{"facility":32,"status":33,"city":184,"state":185,"zip":186,"country":37,"countryCode":38,"cosmosGeoPoint":187,"geoPoint":191,"contacts":20},"Milwaukee","Wisconsin","53226",{"type":40,"coordinates":188},[189,190],-87.90647,43.0389,{"lat":190,"lon":189},{"type":193,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100054097",false,"NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.","ALL","18 Years",{"count":203,"type":204},45,"ESTIMATED","INTERVENTIONAL",[207],"PHASE1","Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[210,211,212,213,214,215,216,217],"Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Carcinoma","Pancreatic Adenocarcinoma","Breast Cancer","Other Solid Tumors","Ovarian Cancer","Myeloid Neoplasms (AML\u002FMDS)",[219,220,221,222,223,224,225,214,216,226,227,228],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR","2026-07-10",{"date":231,"type":232},"2026-07-13","ACTUAL",{"date":234,"type":232},"2023-07-12",{"date":236,"type":204},"2029-07-31",{"name":5,"class":6},18]