[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485926":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":206,"collaborators":21,"id":208,"slug":209,"hasResults":210,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":210,"sex":216,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":21,"studyType":222,"phases":223,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":42,"whyStopped":21,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Cellectis S.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose finding part","EXPERIMENTAL","UCART20x22 tested at several dose levels until the Maximum Tolerated Dose (MTD) and\u002For the Recommended Phase 2 Dose (RP2D) is identified.\n\nDose expansion part: UCART20x22 administered at the RP2D determined during the dose finding part",[13,14],"Biological: UCART20x22","Biological: CLLS52",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","UCART20x22","Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"CLLS52","A monoclonal antibody that recognizes a CD52 antigen",[9],[27],"Alemtuzumab",[29],{"name":30,"affiliation":31,"role":32},"Jeremy Abramson, MD","Harvard Medical School - Massachusetts General","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":21,"email":38},"Cellectis Central Contact","CONTACT","+1 917 580-1088","clinicaltrials@cellectis.com",[40,60,76,92,108,126,142,157,173,191],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The University of Chicago Medical Center (UCMC)","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-87.65005,41.85003,{"lat":52,"lon":51},[55,59],{"name":56,"role":36,"phone":57,"phoneExt":21,"email":58},"Peter Riedell","773-834-5903","priedell@medicine.bsd.uchicago.edu",{"name":56,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":61,"status":42,"city":62,"state":63,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Harvard Medical School - Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":49,"coordinates":66},[67,68],-71.05977,42.35843,{"lat":68,"lon":67},[71,75],{"name":72,"role":36,"phone":73,"phoneExt":21,"email":74},"Jeremy Abramson","617-724-9190","jabramson@mgh.harvard.edu",{"name":72,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":77,"status":42,"city":78,"state":79,"zip":80,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick","New Brunswick","New Jersey","08901",{"type":49,"coordinates":82},[83,84],-74.45182,40.48622,{"lat":84,"lon":83},[87,91],{"name":88,"role":36,"phone":89,"phoneExt":21,"email":90},"Matthew Matasar","732-439-5162","mm3511@cinj.rutgers.edu",{"name":88,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":93,"status":42,"city":94,"state":95,"zip":96,"country":46,"countryCode":47,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Sarah Cannon - St. David South Austin Medical Center","Austin","Texas","78704",{"type":49,"coordinates":98},[99,100],-97.74306,30.26715,{"lat":100,"lon":99},[103,107],{"name":104,"role":36,"phone":105,"phoneExt":21,"email":106},"Aravind Ramakrishnan","512-816-8078","Aravind.Ramakrishnan@hcahealthcare.com",{"name":104,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":109,"status":42,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud","Pierre-Bénite","Auvergne Rhone Alpe","69310","France","FR",{"type":49,"coordinates":116},[117,118],4.82424,45.70359,{"lat":118,"lon":117},[121,125],{"name":122,"role":36,"phone":21,"phoneExt":123,"email":124},"Emmanuel Bachy","+330478862205","emmanuel.bachy@chu-lyon.fr",{"name":122,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":127,"status":42,"city":128,"state":129,"zip":130,"country":113,"countryCode":114,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi","Montpellier","Occitanie","34295",{"type":49,"coordinates":132},[133,134],3.87635,43.61093,{"lat":134,"lon":133},[137,141],{"name":138,"role":36,"phone":139,"phoneExt":21,"email":140},"Guillaume Cartron","(+33)467336733","g-cartron@chu-montpellier.fr",{"name":138,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":143,"status":42,"city":144,"state":21,"zip":145,"country":113,"countryCode":114,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu","Nantes","44093",{"type":49,"coordinates":147},[148,149],-1.55336,47.21725,{"lat":149,"lon":148},[152,156],{"name":153,"role":36,"phone":154,"phoneExt":21,"email":155},"Thomas Gastinne","(+33)240083302","thomas.gastinne@chu-nantes.fr",{"name":153,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":158,"status":42,"city":159,"state":160,"zip":161,"country":113,"countryCode":114,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie","Paris","Île-de-France Region","75010",{"type":49,"coordinates":163},[164,165],2.3488,48.85341,{"lat":165,"lon":164},[168,172],{"name":169,"role":36,"phone":170,"phoneExt":21,"email":171},"Catherine Thieblemont","(+33)0142499236","catherine.thieblemont@aphp.fr",{"name":169,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":174,"status":42,"city":175,"state":176,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona","Pamplona","Navarre","31008","Spain","ES",{"type":49,"coordinates":181},[182,183],-1.64323,42.81687,{"lat":183,"lon":182},[186,190],{"name":187,"role":36,"phone":188,"phoneExt":21,"email":189},"Ana Alfonso","(+34) 948 255 400","aalfonso@unav.es",{"name":187,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":192,"status":42,"city":193,"state":21,"zip":194,"country":178,"countryCode":179,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)","Seville","41013",{"type":49,"coordinates":196},[197,198],-5.97317,37.38283,{"lat":198,"lon":197},[201,205],{"name":202,"role":36,"phone":203,"phoneExt":21,"email":204},"Jose Antonio Perez Simon","(+34)955923000","josea.perez.simon.sspa@juntadendalucia.es",{"name":202,"role":32,"phone":21,"phoneExt":21,"email":21},{"type":207,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100485926","phase-1-study-evaluating-ucart20x22-in-b-cell-non-hodgkin-lymphoma-100485926",false,"NCT05607420","Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma","Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL)","NatHaLi-01","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Relapsed or refractory (R\u002FR) mature B-NHL per 2016 WHO criteria and positive for CD20 and\u002For CD22\n* Subjects with NHL subtypes defined by WHO:\n* Dose-Finding Part: R\u002FR mature B-NHL (except chronic lymphocytic leukemia\u002Fsmall lymphocytic leukemia \\[CLL\u002FSLL\\], Richter's transformation from prior CLL\u002FSLL, Burkitt's lymphoma, and Waldenstrom's macroglobulinemia)\n* Dose-Expansion Part: R\u002FR LBCL, defined as:\n\n  i. DLBCL; ii. High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements; iii. Transformed FL or transformed marginal zone lymphoma (MZL); iv. Follicular lymphoma Grade 3B\n* R\u002FR disease after at least 2 lines of prior treatment, which must have included:\n* An Anti-CD20 MoAb and an anthracycline for DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, primary mediastinal large B-cell lymphoma (PMBCL), or transformed FL or MZL\n* An alkylating agent in combination with an anti-CD20 MoAb for FL\n* An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton's tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)\n* Autologous anti-CD19 CAR T-cell therapy, if approved and available for the indicated lymphoma subtype, unless the subject is unable or is ineligible to receive approved autologous anti-CD19 CAR T-cell therapy (e.g., fail leukapheresis or manufacture, unable to wait for manufacture, CD19 negative disease, etc.)\n* Autologous hematopoietic stem cells must be available prior to the start of the LD regimen if the subject is considered high-risk for prolonged hematologic toxicity.\n\nExclusion Criteria:\n\n* Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to start of LD regimen\n* Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R\u002FR B-NHL with 5 half-lives or within 14 days, whichever is shorter, prior to start of the LD regimen\n* \\> 4 lines of therapy R\u002FR B-NHL prior to start of the LD regimen.\n* Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD\n* Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LD regimen\n* Prior cell or gene therapy (approved or investigational) within 6 months of the start of LD\n* Prior cell or gene therapy (approved or investigational) targeting both CD20 and CD22\n* Autologous HSCT infusion within 6 weeks of the start of LD\n* Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD\n* Active acute or chronic graft versus host disease (GvHD). Subjects should be off all immunosuppressive therapies for at least 6 weeks prior to start of LD\n* Radiotherapy within 8 weeks (except for palliative radiotherapy for specific on-target lesions) (prior to start of LD regimen)\n* Evidence of active central nervous system (CNS) lymphoma or previous CNS involvement of R\u002FR B-NHL\n* Presence of an active and clinically relevant CNS disorder\n* Daily treatment with \\>20 mg prednisone or equivalent\n* Known active infection, or reactivation of a latent infection, whether bacterial or viral, fungal, mycobacterial, or other pathogens\n* History of hypersensitivity to alemtuzumab\n* History of neutralizing anti-drug antibody against alemtuzumab\n* Any known uncontrolled cardiovascular disease within 3 months of enrollment\n* Subjects requiring immunosuppressive treatment\n* Major surgery within 28 days prior to start of LD\n* Evidence of another uncontrolled malignancy within 2 years prior to Screening (except in situ nonmelanoma skin cell cancers and\u002For carcinoma in-situ of the cervix)","ALL","18 Years","80 Years",{"count":220,"type":221},80,"ESTIMATED","INTERVENTIONAL",[224,225],"PHASE1","PHASE2","First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).",[228],"B-cell Non-Hodgkin Lymphoma (B-NHL)",[228,230,231,232,233],"Relapsed\u002FRefractory B-NHL","Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy","Allogeneic","Transcription Activator-Like Effector Nuclease (TALEN®)","2025-08-19",{"date":236,"type":237},"2025-08-24","ACTUAL",{"date":239,"type":237},"2022-11-01",{"date":241,"type":221},"2027-08",{"name":5,"class":6},10]