[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607739":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":69,"studyPopulation":61,"armGroups":70,"interventions":81,"overallOfficials":61,"centralContacts":87,"locations":93,"responsibleParty":364,"collaborators":61,"id":366,"slug":61,"hasResults":367,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":61,"eligibilityCriteria":371,"healthyVolunteers":367,"sex":372,"minAge":373,"maxAge":61,"enrollmentInfo":374,"targetDuration":61,"studyType":377,"phases":378,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":392,"whyStopped":61,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":402},{"fullName":5,"class":6},"Kyowa Kirin Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":61},[9,13,15,17,19,21,23],{"measure":10,"description":11,"timeFrame":12},"Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL\u002FCTCL).","Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (all 72 potentially treated subjects)","Through study completion, an average of 1.5 years",{"measure":10,"description":14,"timeFrame":12},"Vital signs (mmHg in Systolic\u002FDiastolic blood pressure)",{"measure":10,"description":16,"timeFrame":12},"Pulse rate (beats\u002Fmin)",{"measure":10,"description":18,"timeFrame":12},"Respiratory Rate (breath\u002Fmin)",{"measure":10,"description":20,"timeFrame":12},"Temperature (°Celcius)",{"measure":10,"description":22,"timeFrame":12},"ECG parameters (PR interval, QRS interval, QT interval, QTc interval)",{"measure":10,"description":24,"timeFrame":12},"Number of participants with dose-limiting toxicities (DLTs) in Part 1 only (at most 27 participants) and assess maximum tolerated dose (MTD)",[26,29,32,35,37,39,41,43,46,49,52,55,58],{"measure":27,"description":28,"timeFrame":12},"Mean Blood Drug Concentration","The mean drug concentration in the blood",{"measure":30,"description":31,"timeFrame":12},"To evaluate the immunogenicity of KK2223.","Incidence of Anti drug antibodies (ADA) in blood",{"measure":33,"description":34,"timeFrame":12},"To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).","% in Overall Response Rate (ORR)",{"measure":33,"description":36,"timeFrame":12},"% in Compartment Response (if applicable)",{"measure":33,"description":38,"timeFrame":12},"Time unit (week\u002Fmonth) in Duration of Response (DOR)",{"measure":33,"description":40,"timeFrame":12},"Time unit (week\u002Fmonth) in Time To Next Treatment (TTNT) will be evaluated",{"measure":33,"description":42,"timeFrame":12},"Time unit (week\u002Fmonth) in Time To Response (TTR)",{"measure":44,"description":45,"timeFrame":12},"Pharmacokinetic Parameter Maximum Blood Concentration (Cmax)","The maximum drug concentration",{"measure":47,"description":48,"timeFrame":12},"Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC)","A measure of the overall drug exposure over time",{"measure":50,"description":51,"timeFrame":12},"Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)","The time taken to reach the maximum drug concentration",{"measure":53,"description":54,"timeFrame":12},"Pharmacokinetic Parameter Terminal Half-Life (Thalf)","The time required for the drug concentration to decrease by 50%",{"measure":56,"description":57,"timeFrame":12},"Pharmacokinetic Parameter Clearance (CL)","Rate of drug elimination from the body",{"measure":59,"description":60,"timeFrame":12},"Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss)","Theoretical volume of distribution at steady state and reflects the extent of drug istribution into tissues",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":61,"timePerspective":61,"maskingInfo":67},"NON_RANDOMIZED","SEQUENTIAL","This is a sequential design study where participants receive interventions in a stepwise manner. Treatment assignments and doses may be adjusted based on interim safety and efficacy analyses conducted throughout the trial.","TREATMENT",{"masking":68,"maskingDescription":61,"whoMasked":61},"NONE","This is a Phase 1, multicenter, open-label, non randomized study in participants with relapsed or refractory PTCL or CTCL. This study consists of Part 1 (dose-escalation) and Part 2 (backfill). The purpose of this study is to determine the safety, tolerability, PK and pharmacodynamics of K2223 in r\u002Fr T-cell NHL (PTCL or CTCL)",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Part One (Dose Escalation)","EXPERIMENTAL","In Part 1, safety and tolerability of KK2223 in relapsed\u002Frefractory PTCL or CTCL patients will be assessed using a BOIN dose-escalation design.",[76],"Drug: KK2223",{"label":78,"type":73,"description":79,"interventionNames":80},"Part Two (Backfill)","Part 2 will collect additional data, with dose levels and cohort size based on Part 1 results, administering doses approved for tolerability. Backfill cohorts at cleared doses may open, prioritizing Part 1 enrollment.",[76],[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":61},"DRUG","KK2223","Intravenous infusion",[72,78],[88],{"name":89,"role":90,"phone":91,"phoneExt":61,"email":92},"Kyowa Kirin, Inc.","CONTACT","+1-609-919-1100","KKD.Clinical.82@kyowakirin.com",[94,114,129,145,161,177,192,208,224,240,258,273,288,302,320,335,351],{"facility":95,"status":61,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"University of California, Irvine Medical Center - Hematology\u002FOncology","Orange","California","92868","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-117.85311,33.78779,{"lat":105,"lon":104},[108,112],{"name":109,"role":90,"phone":110,"phoneExt":61,"email":111},"Lauren Pinter Brown","7144568200","lpinterb@uci.edu",{"name":109,"role":113,"phone":61,"phoneExt":61,"email":61},"PRINCIPAL_INVESTIGATOR",{"facility":115,"status":61,"city":116,"state":97,"zip":117,"country":99,"countryCode":100,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Stanford University School of Medicine","Stanford","94305",{"type":102,"coordinates":119},[120,121],-122.16608,37.42411,{"lat":121,"lon":120},[124,128],{"name":125,"role":90,"phone":126,"phoneExt":61,"email":127},"Youn Kim","650-723-7893","younkim@stanford.edu",{"name":125,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":130,"status":61,"city":131,"state":132,"zip":133,"country":99,"countryCode":100,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Beth Israel Deaconess Medical Center - Research","Boston","Massachusetts","02215",{"type":102,"coordinates":135},[136,137],-71.05977,42.35843,{"lat":137,"lon":136},[140,144],{"name":141,"role":90,"phone":142,"phoneExt":61,"email":143},"Salvia Jain","617-726-2000","salvia.jain@mgh.harvard.edu",{"name":141,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":146,"status":61,"city":147,"state":148,"zip":149,"country":99,"countryCode":100,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Washington University School of Medicine - Oncology Hospital - Public","St Louis","Missouri","63110",{"type":102,"coordinates":151},[152,153],-90.19789,38.62727,{"lat":153,"lon":152},[156,160],{"name":157,"role":90,"phone":158,"phoneExt":61,"email":159},"Neha Mehta Shah","314.273-8566","mehta-n@wustl.edu",{"name":157,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":162,"status":61,"city":163,"state":164,"zip":165,"country":99,"countryCode":100,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division","Hackensack","New Jersey","07601-2105",{"type":102,"coordinates":167},[168,169],-74.04347,40.88593,{"lat":169,"lon":168},[172,176],{"name":173,"role":90,"phone":174,"phoneExt":61,"email":175},"Tatyana Feldman","551-996-5900","tatyana.feldman@hmhn.org",{"name":173,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":178,"status":61,"city":179,"state":179,"zip":180,"country":99,"countryCode":100,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Memorial Sloan Kettering Cancer Center","New York","10021-6007",{"type":102,"coordinates":182},[183,184],-74.00597,40.71427,{"lat":184,"lon":183},[187,191],{"name":188,"role":90,"phone":189,"phoneExt":61,"email":190},"Jasmine Zain","212-639-3045","zainj1@mskcc.org",{"name":188,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":193,"status":61,"city":194,"state":195,"zip":196,"country":99,"countryCode":100,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Oregon Health & Science University","Portland","Oregon","97239",{"type":102,"coordinates":198},[199,200],-122.67621,45.52345,{"lat":200,"lon":199},[203,207],{"name":204,"role":90,"phone":205,"phoneExt":61,"email":206},"Craig Okada","503-494-8397","okadac@ohsu.edu",{"name":204,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":209,"status":61,"city":210,"state":211,"zip":212,"country":99,"countryCode":100,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"University of Pennsylvania - Abramson Cancer Center","Philadelphia","Pennsylvania","19104",{"type":102,"coordinates":214},[215,216],-75.16362,39.95238,{"lat":216,"lon":215},[219,223],{"name":220,"role":90,"phone":221,"phoneExt":61,"email":222},"Stefan Barta","215-728-2674","Stefan.Barta@pennmedicine.upenn.edu",{"name":220,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":225,"status":61,"city":226,"state":227,"zip":228,"country":99,"countryCode":100,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"The University of Texas - MD Anderson Cancer Center","Houston","Texas","77030",{"type":102,"coordinates":230},[231,232],-95.36327,29.76328,{"lat":232,"lon":231},[235,239],{"name":236,"role":90,"phone":237,"phoneExt":61,"email":238},"Ranjit Nair","171-379-2860","rnair@mdanderson.org",{"name":236,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":241,"status":61,"city":242,"state":243,"zip":244,"country":245,"countryCode":246,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Istituto di Candiolo, IRCCS - Oncologia Medica ed Ematologia","Candiolo","Torino","10060","Italy","IT",{"type":102,"coordinates":248},[249,250],7.59812,44.95858,{"lat":250,"lon":249},[253,257],{"name":254,"role":90,"phone":255,"phoneExt":61,"email":256},"Umberto Vitolo","390116335934","umberto.vitolo@ircc.it",{"name":254,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":259,"status":61,"city":260,"state":61,"zip":261,"country":245,"countryCode":246,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Azienda Ospedaliera Papa Giovanni XXIII - Ematologia","Bergamo","24127",{"type":102,"coordinates":263},[264,265],9.66721,45.69601,{"lat":265,"lon":264},[268,272],{"name":269,"role":90,"phone":270,"phoneExt":61,"email":271},"Giuseppe Gritti","39035269492","giuseppe_gritti@yahoo.it",{"name":269,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":274,"status":61,"city":275,"state":61,"zip":276,"country":245,"countryCode":246,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Azienda Ospedaliero Universitaria di Bologna IRCCS (Policlinico di Sant'Orsola) - Ematologia","Bologna","40138",{"type":102,"coordinates":278},[279,280],11.33875,44.49381,{"lat":280,"lon":279},[283,287],{"name":284,"role":90,"phone":285,"phoneExt":61,"email":286},"Luigi Zinzani Pier","390516363680","pierluigi.zinzani@unibo.it",{"name":284,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":289,"status":61,"city":243,"state":61,"zip":290,"country":245,"countryCode":246,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"AOU Citta' della Salute e della Scienza di Torino Ospedale Molinette, Ematologia Universitaria","10126",{"type":102,"coordinates":292},[293,294],11.99138,44.88856,{"lat":294,"lon":293},[297,301],{"name":298,"role":90,"phone":299,"phoneExt":61,"email":300},"Federica Cavallo","390116334264","f.cavallo@unito.it",{"name":298,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":303,"status":61,"city":304,"state":305,"zip":306,"country":307,"countryCode":308,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Hospital Clinic De Barcelona - Hematología","Badalona","Barcelona","8036","Spain","ES",{"type":102,"coordinates":310},[311,312],2.24741,41.45004,{"lat":312,"lon":311},[315,319],{"name":316,"role":90,"phone":317,"phoneExt":61,"email":318},"Pablo Mozas","34 93 227 22 71","mozas@clinic.cat",{"name":316,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":321,"status":61,"city":322,"state":305,"zip":323,"country":307,"countryCode":308,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Institut Català d'Oncologia (ICO) - ICO L'Hospitalet - Hematologia","L'Hospitalet de Llobregat","8907",{"type":102,"coordinates":325},[326,327],2.10028,41.35967,{"lat":327,"lon":326},[330,334],{"name":331,"role":90,"phone":332,"phoneExt":61,"email":333},"Eva Domingo Domenech","34932607822","edomingo@iconcologia.net",{"name":331,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":336,"status":61,"city":337,"state":338,"zip":339,"country":307,"countryCode":308,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Clinica Universidad de Navarra - Hematología","Pamplona","Navarre","31008",{"type":102,"coordinates":341},[342,343],-1.64323,42.81687,{"lat":343,"lon":342},[346,350],{"name":347,"role":90,"phone":348,"phoneExt":61,"email":349},"Miguel Canales Albendea","34917277116","macanales@unav.es",{"name":347,"role":113,"phone":61,"phoneExt":61,"email":61},{"facility":352,"status":61,"city":353,"state":61,"zip":354,"country":307,"countryCode":308,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"Clinica Universidad de Navarra - Hematología y Hemoterapia","Madrid","28027",{"type":102,"coordinates":356},[357,358],-3.70256,40.4165,{"lat":358,"lon":357},[361,362],{"name":347,"role":90,"phone":348,"phoneExt":61,"email":349},{"name":363,"role":113,"phone":61,"phoneExt":61,"email":61},"Migue Canales Albendea",{"type":365,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100607739",false,"NCT07192471","A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin Lymphoma","A Phase 1, Multicenter, Open-label, Non-randomized, Dose-escalation and Backfill Study of KK2223 in Participants With Relapsed or Refractory T-cell Non Hodgkin Lymphoma","Inclusion Criteria:\n\n* Adults (≥18 years) with confirmed T-cell lymphoma subtypes: PTCL (including nodal T-follicular helper cell lymphoma, ALCL, PTCL NOS) for Parts 1 and 2; CTCL (mycosis fungoides or Sézary syndrome, stages IIB-IV) for Parts 1 and 2, with specific disease involvement criteria in Part 2.\n* PTCL participants must have relapsed\u002Frefractory\u002Fintolerant to ≥1 systemic therapy; CD30+ PTCL must have prior brentuximab vedotin treatment or intolerance, and\u002For ALK-positive ALCL participants should have previously received crizotinib if indicated (crizotinib administration is applicable to US sites only). CTCL participants must have relapsed\u002Frefractory\u002Fintolerant to ≥2 systemic therapies.\n* Availability of tumor tissue (current or archival) is required.\n* Measurable disease required: nodal\u002Fextranodal lesions for PTCL and assessable skin disease for CTCL.\n* ECOG performance status 0-1; adequate neutrophils (≥1000\u002FµL), platelets (≥75,000\u002FµL), renal function (creatinine clearance ≥60 mL\u002Fmin), liver function within defined limits, and total bilirubin ≤1.5× ULN (up to 3× ULN with Gilbert's syndrome).\n* Body weight 40 kg to ≤ 200 kg\n* Life expectancy ≥3 months.\n* Negative pregnancy test for females of childbearing potential; contraception required for females and males with partners of childbearing potential during and after treatment.\n* Restrictions on gamete donation and freezing during and after treatment.\n* Ability to provide informed consent and comply with study procedures. -\n\nExclusion Criteria:\n\n* Recent autologous or allogeneic transplant within 120 days before treatment; active GVHD or ongoing immunosuppression after allogeneic transplant; prior HSCT and with active VOD\u002FSOS\n* Pregnant or breastfeeding females, or those intending pregnancy.\n* History of HIV, HBV, or HCV infections generally excluded, except for controlled or resolved cases as defined.\n* Uncontrolled infections requiring antibiotics, antivirals, or antifungals at screening through treatment start.\n* Significant medical history or complications within six months prior to enrollment, including advanced congestive heart failure (NYHA Class III or higher), recent unstable angina or myocardial infarction, autoimmune diseases requiring systemic immunosuppressive therapy, active or uncontrolled ocular diseases, Grade 3 or 4 peripheral neuropathy, or other poorly controlled conditions as judged by the investigator (e.g., uncontrolled hypertension, diabetes, or arrhythmias).\n* Use of other investigational drugs within 14 days or 5 half-lives before treatment.\n* Steroid use over 10 mg\u002Fday prednisone equivalent within 14 days prior, except limited corticosteroid use with specific tapering guidelines; topical steroids allowed under conditions for CTCL.\n* Major surgery, radiotherapy, chemotherapy, or other anti-cancer treatments within 14 days or 5 half-lives before treatment.\n* Prior mogamulizumab use within six months before treatment; associated rash must be ruled out if \\>6 months.\n* Known history of Grade ≥ 3 hypersensitivity to mogamulizumab.\n* Failure to recover from prior non-hematologic toxicities to Grade 0 or 1 (except alopecia and mild neuropathy).\n* Prolonged QT\u002FQTc interval (e.g., QTcF \\>480 ms).\n* Active second primary malignancies except specified non-exclusionary cases.\n* CNS involvement.\n* Any condition that may impair compliance or study completion as judged by the Investigator.\n* Known hypersensitivity to any excipients in the drug formulation.","ALL","18 Years",{"count":375,"type":376},72,"ESTIMATED","INTERVENTIONAL",[379],"PHASE1","The purpose of this study is to determine the safety, tolerability, PK and pharmacodynamics of KK2223 in adult participants with relapsed or refractory peripheral T cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL).",[382],"T-cell NHL (PTCL or CTCL)",[384,385,386,387,388,389,390,391],"Neoplasms","Lymphoma","Immune System Diseases","First in Human","Lymphoma, T-Cell, Cutaneous +","Lymphoma, T-Cell, Peripheral","Mycosis fungoides","Sezary Syndrome","NOT_YET_RECRUITING","2026-06-29",{"date":395,"type":396},"2026-07-01","ACTUAL",{"date":398,"type":376},"2026-08",{"date":400,"type":376},"2030-09",{"name":89,"class":6},17]