[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438478":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":79,"studyPopulation":19,"armGroups":80,"interventions":98,"overallOfficials":115,"centralContacts":120,"locations":126,"responsibleParty":385,"collaborators":19,"id":387,"slug":19,"hasResults":388,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":388,"sex":394,"minAge":395,"maxAge":19,"enrollmentInfo":396,"targetDuration":19,"studyType":399,"phases":400,"briefSummary":403,"conditions":404,"keywords":19,"overallStatus":129,"whyStopped":19,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":415},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":19},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753","DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.","Up to 28 days",{"measure":14,"description":15,"timeFrame":16},"Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment.","ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.","Up to 15 years",{"measure":18,"description":19,"timeFrame":16},"Phase 2: ORR as per central assessment for KITE-753",null,[21,23,25,28,31,34,37,40,43,45,48,51,53,55,57,59,61,63,65,67,69,71],{"measure":22,"description":19,"timeFrame":16},"Phase 1a\u002Fb: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753",{"measure":24,"description":19,"timeFrame":16},"Phase 1a\u002Fb: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753",{"measure":26,"description":27,"timeFrame":16},"Phase 1a\u002Fb: Time To Next Treatment (TTNT) for KITE-363 and KITE-753","TTNT is defined as the time from KITE-363 or KITE-753 infusion to the next anticancer treatment (including stem cell transplantation \\[SCT\\]) or death from any cause, whichever occurs first.",{"measure":29,"description":30,"timeFrame":16},"Phase 1a\u002Fb: Complete Response (CR) Rate for KITE-363 and KITE-753","CR rate is defined as the incidence of a CR by the IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.",{"measure":32,"description":33,"timeFrame":16},"Phase 1a\u002Fb: Duration of Response (DOR) for KITE-363 and KITE-753","DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression per the IWG Lugano Classification or death due to any cause, whichever occurs first.",{"measure":35,"description":36,"timeFrame":16},"Phase 1a\u002Fb: Progression-Free Survival (PFS) for KITE-363 and KITE-753","PFS is defined as the time of KITE-363 or KITE-753 infusion to disease progression per IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) or death from any cause, whichever occurs first.",{"measure":38,"description":39,"timeFrame":16},"Phase 1a\u002Fb: Overall Survival (OS) for KITE-363 and KITE-753","OS is defined as the time from KITE-363 or KITE-753 infusion to death from any cause.",{"measure":41,"description":19,"timeFrame":42},"Phase 1a\u002Fb: Percentage of Participants who Develop Antibodies to KITE-363 and KITE-753 Chimeric Antigen Receptor (CAR) T Cells","Enrollment; up to 12 months",{"measure":44,"description":19,"timeFrame":16},"Phase 1a\u002Fb: Levels of KITE-363 and KITE-753 CAR T Cells",{"measure":46,"description":19,"timeFrame":47},"Phase 1a\u002Fb: Peak Serum Levels of Key Analytes Homeostatic\u002FProliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15","Up to 3 months",{"measure":49,"description":50,"timeFrame":47},"Phase 1a\u002Fb: Peak Serum Levels of Key Analytes Inflammatory\u002FImmune Modulating Cytokines: IFN-γ, IL-6, IL-10, IL-17, IL-1RA, Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), and Tumor Necrosis Factor-Alpha (TNF-α)","IFN-γ=Interferon-Gamma, IL-1 Receptor Antagonist=IL-1RA",{"measure":52,"description":19,"timeFrame":47},"Phase 1a\u002Fb: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP)",{"measure":54,"description":19,"timeFrame":47},"Phase 1a\u002Fb: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Ferritin",{"measure":56,"description":19,"timeFrame":47},"Phase 1a\u002Fb: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Soluble IL-2 Receptor Alpha (Sil-2Rα)",{"measure":58,"description":19,"timeFrame":47},"Phase 1a\u002Fb: Peak Serum Levels of Key Analytes Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1)",{"measure":60,"description":19,"timeFrame":47},"Phase 1a\u002Fb: Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme B",{"measure":62,"description":19,"timeFrame":16},"Phase 2: CR rate for KITE-753",{"measure":64,"description":19,"timeFrame":16},"Phase 2: DOR for KITE-753",{"measure":66,"description":19,"timeFrame":16},"Phase 2: PFS for KITE-753",{"measure":68,"description":19,"timeFrame":16},"Phase 2: OS for KITE-753",{"measure":70,"description":19,"timeFrame":16},"Phase 2: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-753",{"measure":72,"description":19,"timeFrame":16},"Phase 2: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-753",{"allocation":74,"interventionModel":75,"interventionModelDescription":19,"primaryPurpose":76,"observationalModel":19,"timePerspective":19,"maskingInfo":77},"NA","SEQUENTIAL","TREATMENT",{"masking":78,"maskingDescription":19,"whoMasked":19},"NONE","Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.",[81,89,94],{"label":82,"type":83,"description":84,"interventionNames":85},"Phase 1 a\u002Fb: KITE-363","EXPERIMENTAL","Phase 1a (Dose escalation): Participants with r\u002Fr large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-363.\n\nPhase 1b (Dose expansion): After completion of dose escalation, additional participants with r\u002Fr B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-363 at 1 or more dose-level deemed to be tolerable.\n\n\\[Recruitment completed for this arm\\]",[86,87,88],"Drug: Cyclophosphamide","Drug: Fludarabine","Biological: KITE-363",{"label":90,"type":83,"description":91,"interventionNames":92},"Phase 1 a\u002Fb: KITE-753","Phase 1a (Dose escalation): Participants with r\u002Fr large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-753.\n\nPhase 1b (Dose expansion): After completion of dose escalation, additional participants with r\u002Fr B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-753 at 1 or more dose-level deemed to be tolerable.\n\n\\[Recruitment open for frontline LBCL and r\u002Fr MCL for this arm\\]",[86,87,93],"Biological: KITE-753",{"label":95,"type":83,"description":96,"interventionNames":97},"Phase 2: KITE-753","Participants with r\u002Fr large B-cell lymphoma who have received at least 2 prior lines of systemic therapy will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells \u002Fkg intravenously (IV).",[86,87,93],[99,104,107,112],{"type":100,"name":101,"description":102,"armGroupLabels":103,"otherNames":19},"DRUG","Cyclophosphamide","Lymphodepleting chemotherapy administered intravenously",[82,90,95],{"type":100,"name":105,"description":102,"armGroupLabels":106,"otherNames":19},"Fludarabine",[82,90,95],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":19},"BIOLOGICAL","KITE-363","A single infusion of CAR-transduced autologous T cells administered intravenously",[82],{"type":108,"name":113,"description":110,"armGroupLabels":114,"otherNames":19},"KITE-753",[90,95],[116],{"name":117,"affiliation":118,"role":119},"Kite Study Director","Kite, A Gilead Company","STUDY_DIRECTOR",[121],{"name":122,"role":123,"phone":124,"phoneExt":19,"email":125},"Medical Information","CONTACT","844-454-5483(1-844-454-KITE)","medinfo@kitepharma.com",[127,141,151,160,170,180,190,200,210,220,229,238,248,258,264,274,283,293,305,314,324,334,345,351,362,373],{"facility":128,"status":129,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":19},"Banner MD Anderson Cancer Center","RECRUITING","Gilbert","Arizona","85234","United States","US",{"type":136,"coordinates":137},"Point",[138,139],-111.78903,33.35283,{"lat":139,"lon":138},{"facility":142,"status":129,"city":143,"state":144,"zip":145,"country":133,"countryCode":134,"cosmosGeoPoint":146,"geoPoint":150,"contacts":19},"City of Hope (City of Hope National Medical Center, City of Hope Medical Center)","Duarte","California","91010",{"type":136,"coordinates":147},[148,149],-117.97729,34.13945,{"lat":149,"lon":148},{"facility":152,"status":129,"city":153,"state":144,"zip":154,"country":133,"countryCode":134,"cosmosGeoPoint":155,"geoPoint":159,"contacts":19},"Stanford Cancer Institute","Stanford","94305",{"type":136,"coordinates":156},[157,158],-122.16608,37.42411,{"lat":158,"lon":157},{"facility":161,"status":129,"city":162,"state":163,"zip":164,"country":133,"countryCode":134,"cosmosGeoPoint":165,"geoPoint":169,"contacts":19},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":136,"coordinates":166},[167,168],-82.45843,27.94752,{"lat":168,"lon":167},{"facility":171,"status":129,"city":172,"state":173,"zip":174,"country":133,"countryCode":134,"cosmosGeoPoint":175,"geoPoint":179,"contacts":19},"Northside Hospital","Atlanta","Georgia","30342",{"type":136,"coordinates":176},[177,178],-84.38798,33.749,{"lat":178,"lon":177},{"facility":181,"status":129,"city":182,"state":183,"zip":184,"country":133,"countryCode":134,"cosmosGeoPoint":185,"geoPoint":189,"contacts":19},"Midwestern Regional Medical Center, Inc.City of Hope Chicago","Park Ridge","Illinois","60068",{"type":136,"coordinates":186},[187,188],-87.84062,42.01114,{"lat":188,"lon":187},{"facility":191,"status":129,"city":192,"state":193,"zip":194,"country":133,"countryCode":134,"cosmosGeoPoint":195,"geoPoint":199,"contacts":19},"Norton Cancer Institute, St. Matthews Campus","Shelbyville","Kentucky","40065",{"type":136,"coordinates":196},[197,198],-85.22357,38.21201,{"lat":198,"lon":197},{"facility":201,"status":129,"city":202,"state":203,"zip":204,"country":133,"countryCode":134,"cosmosGeoPoint":205,"geoPoint":209,"contacts":19},"University of MD, Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":136,"coordinates":206},[207,208],-76.61219,39.29038,{"lat":208,"lon":207},{"facility":211,"status":129,"city":212,"state":213,"zip":214,"country":133,"countryCode":134,"cosmosGeoPoint":215,"geoPoint":219,"contacts":19},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":136,"coordinates":216},[217,218],-74.04347,40.88593,{"lat":218,"lon":217},{"facility":221,"status":129,"city":222,"state":222,"zip":223,"country":133,"countryCode":134,"cosmosGeoPoint":224,"geoPoint":228,"contacts":19},"Columbia University Irving Medical Center","New York","10032",{"type":136,"coordinates":225},[226,227],-74.00597,40.71427,{"lat":227,"lon":226},{"facility":230,"status":129,"city":231,"state":222,"zip":232,"country":133,"countryCode":134,"cosmosGeoPoint":233,"geoPoint":237,"contacts":19},"University of Rochester Medical Center","Rochester","14642",{"type":136,"coordinates":234},[235,236],-77.61556,43.15478,{"lat":236,"lon":235},{"facility":239,"status":129,"city":240,"state":241,"zip":242,"country":133,"countryCode":134,"cosmosGeoPoint":243,"geoPoint":247,"contacts":19},"The Ohio State University Wexner Medical Center - James Cancer Hospital","Columbus","Ohio","43210",{"type":136,"coordinates":244},[245,246],-82.99879,39.96118,{"lat":246,"lon":245},{"facility":249,"status":129,"city":250,"state":251,"zip":252,"country":133,"countryCode":134,"cosmosGeoPoint":253,"geoPoint":257,"contacts":19},"Tennessee Oncology, PLLC - Investigational Drug Services","Nashville","Tennessee","37203",{"type":136,"coordinates":254},[255,256],-86.78444,36.16589,{"lat":256,"lon":255},{"facility":259,"status":129,"city":250,"state":251,"zip":260,"country":133,"countryCode":134,"cosmosGeoPoint":261,"geoPoint":263,"contacts":19},"Vanderbilt University","37232",{"type":136,"coordinates":262},[255,256],{"lat":256,"lon":255},{"facility":265,"status":129,"city":266,"state":267,"zip":268,"country":133,"countryCode":134,"cosmosGeoPoint":269,"geoPoint":273,"contacts":19},"St. David's Medical Center","Austin","Texas","78704",{"type":136,"coordinates":270},[271,272],-97.74306,30.26715,{"lat":272,"lon":271},{"facility":275,"status":129,"city":276,"state":267,"zip":277,"country":133,"countryCode":134,"cosmosGeoPoint":278,"geoPoint":282,"contacts":19},"The University of Texas, MD Anderson Cancer Center","Houston","77030",{"type":136,"coordinates":279},[280,281],-95.36327,29.76328,{"lat":281,"lon":280},{"facility":284,"status":129,"city":285,"state":286,"zip":287,"country":133,"countryCode":134,"cosmosGeoPoint":288,"geoPoint":292,"contacts":19},"Virginia Oncology Associates","Norfolk","Virginia","23502",{"type":136,"coordinates":289},[290,291],-76.28522,36.84681,{"lat":291,"lon":290},{"facility":294,"status":129,"city":295,"state":296,"zip":297,"country":298,"countryCode":299,"cosmosGeoPoint":300,"geoPoint":304,"contacts":19},"Royal North Shore Hospital","St Leonards","New South Wales","2065","Australia","AU",{"type":136,"coordinates":301},[302,303],151.19836,-33.82344,{"lat":303,"lon":302},{"facility":306,"status":129,"city":307,"state":296,"zip":308,"country":298,"countryCode":299,"cosmosGeoPoint":309,"geoPoint":313,"contacts":19},"Concord Repatriation General Hospital","Sydney","2139",{"type":136,"coordinates":310},[311,312],151.20732,-33.86785,{"lat":312,"lon":311},{"facility":315,"status":129,"city":316,"state":317,"zip":318,"country":298,"countryCode":299,"cosmosGeoPoint":319,"geoPoint":323,"contacts":19},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":136,"coordinates":320},[321,322],138.59863,-34.92866,{"lat":322,"lon":321},{"facility":325,"status":129,"city":326,"state":327,"zip":328,"country":298,"countryCode":299,"cosmosGeoPoint":329,"geoPoint":333,"contacts":19},"Epworth Healthcare","East Melbourne","Victoria","3002",{"type":136,"coordinates":330},[331,332],144.9879,-37.81667,{"lat":332,"lon":331},{"facility":335,"status":129,"city":336,"state":19,"zip":337,"country":338,"countryCode":339,"cosmosGeoPoint":340,"geoPoint":344,"contacts":19},"Jewish General Hospital","Montreal","H3T 1E2","Canada","CA",{"type":136,"coordinates":341},[342,343],-73.58781,45.50884,{"lat":343,"lon":342},{"facility":346,"status":129,"city":336,"state":19,"zip":347,"country":338,"countryCode":339,"cosmosGeoPoint":348,"geoPoint":350,"contacts":19},"McGill University Health Center","H4A 0B1",{"type":136,"coordinates":349},[342,343],{"lat":343,"lon":342},{"facility":352,"status":129,"city":353,"state":19,"zip":354,"country":355,"countryCode":356,"cosmosGeoPoint":357,"geoPoint":361,"contacts":19},"Universitatsklinikum Wurzburg","Würzburg","97080","Germany","DE",{"type":136,"coordinates":358},[359,360],9.95121,49.79391,{"lat":360,"lon":359},{"facility":363,"status":129,"city":364,"state":19,"zip":365,"country":366,"countryCode":367,"cosmosGeoPoint":368,"geoPoint":372,"contacts":19},"Academisch Medisch Centrum","Amsterdam","1105 AZ","Netherlands","NL",{"type":136,"coordinates":369},[370,371],4.88969,52.37403,{"lat":371,"lon":370},{"facility":374,"status":375,"city":376,"state":19,"zip":377,"country":378,"countryCode":379,"cosmosGeoPoint":380,"geoPoint":384,"contacts":19},"King's College Hospital","COMPLETED","London","SE5 9RS","United Kingdom","UK",{"type":136,"coordinates":381},[382,383],-0.12574,51.50853,{"lat":383,"lon":382},{"type":386,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100438478",false,"NCT04989803","Study of KITE-363 or KITE-753 in Participants With Relapsed and\u002For Refractory B-cell Lymphoma","A Phase 1\u002F2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19\u002FCD20 CAR T-cell Therapies, in Subjects With Relapsed and\u002For Refractory B-cell Lymphoma","PALISADES-1","Key Inclusion Criteria: for Phase 1a\u002Fb and Phase 2\n\n* Relapsed and\u002For refractory B-cell lymphoma (R\u002FR BCL).\n* At least 1 measurable lesion.\n* Adequate organ and bone marrow (BM) function.\n\nKey Exclusion Criteria: for Phase 1a\u002Fb and Phase 2\n\n\\- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.\n\n* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.\n* History of allogeneic stem cell transplant (allo-SCT).\n* Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.\n* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) (hepatitis B surface \\[HBs\\] antigen \\[HBsAg\\] positive) infection, or hepatitis C (anti-hepatitis C virus \\[HCV\\] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.\n* Individuals with suspicion and\u002For evidence of primary or secondary CNS lymphoma.\n* History or presence of a CNS disorder.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.\n* Primary immunodeficiency.\n* History of autoimmune disease resulting in or requiring systemic immunosuppression and\u002For systemic disease-modifying agents within the last 90 days.\n* Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and\u002For transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.\n* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":397,"type":398},247,"ESTIMATED","INTERVENTIONAL",[401,402],"PHASE1","PHASE2","The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and\u002For refractory B-cell lymphoma.",[405],"Relapsed and\u002For Refractory B-cell Lymphoma","2026-06-26",{"date":408,"type":409},"2026-06-29","ACTUAL",{"date":411,"type":409},"2021-10-27",{"date":413,"type":398},"2030-02",{"name":118,"class":6},26]