[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cellectis S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100374056","phase-1-phase-12-study-of-ucart22-in-patients-with-relapsed-or-refractory-cd22-b-cell-acute-lymphoblastic-leukemia-balli-01-100374056",false,"NCT04150497","Phase 1\u002F2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)","Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n* B-ALL blast cells expressing CD22\n* Diagnosed with R\u002FR B-ALL\n* Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen\n\nExclusion Criteria:\n\n-Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment","ALL","15 Years","50 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)",[28],"B-cell Acute Lymphoblastic Leukemia",[30,31,32,33,34],"B-cell Acute Lymphoblastic Leukemia (B-ALL)","Relapse\u002FRefractory B-ALL","Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy","Allogeneic","Transcription Activator-Like Effector Nuclease (TALEN®)","RECRUITING","2025-09-08",{"date":38,"type":39},"2025-09-09","ACTUAL",{"date":41,"type":39},"2019-10-14",{"date":43,"type":21},"2026-06-30",{"name":45,"class":46},"Cellectis S.A.","INDUSTRY",19,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100485926","phase-1-study-evaluating-ucart20x22-in-b-cell-non-hodgkin-lymphoma-100485926","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)","18 Years","80 Years",{"count":59,"type":21},80,[24,25],"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).",[63],"B-cell Non-Hodgkin Lymphoma (B-NHL)",[63,65,32,33,34],"Relapsed\u002FRefractory B-NHL","2025-08-19",{"date":68,"type":39},"2025-08-24",{"date":70,"type":39},"2022-11-01",{"date":72,"type":21},"2027-08",{"name":45,"class":46},10,""]