[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485926":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":203,"collaborators":21,"id":205,"slug":21,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":206,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":21,"studyType":218,"phases":219,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":42,"whyStopped":21,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"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",[40,59,75,91,107,124,140,155,171,188],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The University of Chicago Medical Center (UCMC)","RECRUITING","Chicago","Illinois","60637","United States",{"type":48,"coordinates":49},"Point",[50,51],-87.65005,41.85003,{"lat":51,"lon":50},[54,58],{"name":55,"role":36,"phone":56,"phoneExt":21,"email":57},"Peter Riedell","773-834-5903","priedell@medicine.bsd.uchicago.edu",{"name":55,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":60,"status":42,"city":61,"state":62,"zip":63,"country":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Harvard Medical School - Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":48,"coordinates":65},[66,67],-71.05977,42.35843,{"lat":67,"lon":66},[70,74],{"name":71,"role":36,"phone":72,"phoneExt":21,"email":73},"Jeremy Abramson","617-724-9190","jabramson@mgh.harvard.edu",{"name":71,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":76,"status":42,"city":77,"state":78,"zip":79,"country":46,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick","New Brunswick","New Jersey","08901",{"type":48,"coordinates":81},[82,83],-74.45182,40.48622,{"lat":83,"lon":82},[86,90],{"name":87,"role":36,"phone":88,"phoneExt":21,"email":89},"Matthew Matasar","732-439-5162","mm3511@cinj.rutgers.edu",{"name":87,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":92,"status":42,"city":93,"state":94,"zip":95,"country":46,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Sarah Cannon - St. David South Austin Medical Center","Austin","Texas","78704",{"type":48,"coordinates":97},[98,99],-97.74306,30.26715,{"lat":99,"lon":98},[102,106],{"name":103,"role":36,"phone":104,"phoneExt":21,"email":105},"Aravind Ramakrishnan","512-816-8078","Aravind.Ramakrishnan@hcahealthcare.com",{"name":103,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":108,"status":42,"city":109,"state":110,"zip":111,"country":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud","Pierre-Bénite","Auvergne Rhone Alpe","69310","France",{"type":48,"coordinates":114},[115,116],4.82424,45.70359,{"lat":116,"lon":115},[119,123],{"name":120,"role":36,"phone":21,"phoneExt":121,"email":122},"Emmanuel Bachy","+330478862205","emmanuel.bachy@chu-lyon.fr",{"name":120,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":125,"status":42,"city":126,"state":127,"zip":128,"country":112,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi","Montpellier","Occitanie","34295",{"type":48,"coordinates":130},[131,132],3.87635,43.61093,{"lat":132,"lon":131},[135,139],{"name":136,"role":36,"phone":137,"phoneExt":21,"email":138},"Guillaume Cartron","(+33)467336733","g-cartron@chu-montpellier.fr",{"name":136,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":141,"status":42,"city":142,"state":21,"zip":143,"country":112,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu","Nantes","44093",{"type":48,"coordinates":145},[146,147],-1.55336,47.21725,{"lat":147,"lon":146},[150,154],{"name":151,"role":36,"phone":152,"phoneExt":21,"email":153},"Thomas Gastinne","(+33)240083302","thomas.gastinne@chu-nantes.fr",{"name":151,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":156,"status":42,"city":157,"state":158,"zip":159,"country":112,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie","Paris","Île-de-France Region","75010",{"type":48,"coordinates":161},[162,163],2.3488,48.85341,{"lat":163,"lon":162},[166,170],{"name":167,"role":36,"phone":168,"phoneExt":21,"email":169},"Catherine Thieblemont","(+33)0142499236","catherine.thieblemont@aphp.fr",{"name":167,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":172,"status":42,"city":173,"state":174,"zip":175,"country":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona","Pamplona","Navarre","31008","Spain",{"type":48,"coordinates":178},[179,180],-1.64323,42.81687,{"lat":180,"lon":179},[183,187],{"name":184,"role":36,"phone":185,"phoneExt":21,"email":186},"Ana Alfonso","(+34) 948 255 400","aalfonso@unav.es",{"name":184,"role":32,"phone":21,"phoneExt":21,"email":21},{"facility":189,"status":42,"city":190,"state":21,"zip":191,"country":176,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)","Seville","41013",{"type":48,"coordinates":193},[194,195],-5.97317,37.38283,{"lat":195,"lon":194},[198,202],{"name":199,"role":36,"phone":200,"phoneExt":21,"email":201},"Jose Antonio Perez Simon","(+34)955923000","josea.perez.simon.sspa@juntadendalucia.es",{"name":199,"role":32,"phone":21,"phoneExt":21,"email":21},{"type":204,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","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":216,"type":217},80,"ESTIMATED","INTERVENTIONAL",[220,221],"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).",[224],"B-cell Non-Hodgkin Lymphoma (B-NHL)",[224,226,227,228,229],"Relapsed\u002FRefractory B-NHL","Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy","Allogeneic","Transcription Activator-Like Effector Nuclease (TALEN®)","2025-08-19",{"date":232,"type":233},"2025-08-24","ACTUAL",{"date":235,"type":233},"2022-11-01",{"date":237,"type":217},"2027-08",{"name":5,"class":6},10]