[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576720":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":51,"interventions":59,"overallOfficials":73,"centralContacts":78,"locations":87,"responsibleParty":104,"collaborators":106,"id":110,"slug":44,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":44,"enrollmentInfo":119,"targetDuration":44,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":44,"overallStatus":90,"whyStopped":44,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"University of Utah","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":44},[9,13,16,18],{"measure":10,"description":11,"timeFrame":12},"The complete response (CR) rate at D30 post CAR-T(+\u002F- 7 days) post CAR-T administration per Lugano 2014 criteria.","To evaluate the efficacy of SOC CAR T-cell therapy in patients with R\u002FR large B-cell lymphoma following bridging with lonca-R.","1 month",{"measure":14,"description":15,"timeFrame":12},"Duration of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 post CAR-T (+\u002F- 7 days).","To evaluate toxicities post CAR-T",{"measure":17,"description":15,"timeFrame":12},"Severity of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 (+\u002F- 7 days).",{"measure":19,"description":15,"timeFrame":12},"Rate of infections D30 (+\u002F- 7 days).",[21,25,28,31,33,35,38,40,42],{"measure":22,"description":23,"timeFrame":24},"CD19 expression as measured by flow cytometry and IHC on biopsies obtained pre- and post-lonca-R (optional) and post-CAR-T (optional but strongly recommended)","To determine whether CD19 expression is reduced in patients who receive bridging with lonca-R prior to CAR-T.","5 years",{"measure":26,"description":27,"timeFrame":12},"ORR defined as the proportion of subjects achieving a confirmed PR or CR at D30 (+\u002F- 7 days) post CAR-T per Lugano 2014 criteria1.","To evaluate the level of disease control provided by bridging lonca-R",{"measure":29,"description":27,"timeFrame":30},"Best response rate per Lugano 2014 criteria following CAR-T (based on imaging up until D90 post CAR-T)","3 months",{"measure":32,"description":27,"timeFrame":24},"ORR defined as the proportion of subjects achieving a confirmed PR or CR post lonca-R (pre-CAR-T)",{"measure":34,"description":27,"timeFrame":24},"Level of disease control (measured as percentage) with lonca-R as evaluated by CT measurements and metabolic tumor volume on PET pre and post Lonca-R",{"measure":36,"description":37,"timeFrame":24},"The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0)","To assess the safety and tolerability of lonca-R in the study population.",{"measure":39,"description":37,"timeFrame":24},"The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.",{"measure":41,"description":37,"timeFrame":24},"The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.",{"measure":43,"description":37,"timeFrame":24},"The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NA","SINGLE_GROUP","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE",[52],{"label":53,"type":54,"description":55,"interventionNames":56},"Treatment: All Patients","EXPERIMENTAL","The study will investigate the effectiveness of Loncastuximab tesirine and Rituximab (Lonca-R) prior to standard of care CAR-T cell therapy.",[57,58],"Drug: Loncastuximab Tesirine","Drug: Rituximab",[60,67],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Loncastuximab Tesirine","Patients will receive Loncastuximab Tesirine intravenously for 1-6 cycles (every 21 days) prior to standard of care CAR-T cell therapy.",[53],[66],"ZYNLONTA",{"type":61,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Rituximab","Rituximab is administered intravenously for 1-6 cycles (every 21 days) prior to standard of care CAR-T cell therapy.",[53],[72],"RITUXAN",[74],{"name":75,"affiliation":76,"role":77},"Narendranath Epperla, MD, MS, FACP","Huntsman Cancer Institute\u002F University of Utah","PRINCIPAL_INVESTIGATOR",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":44,"email":83},"Rachel Kingsford","CONTACT","801-585-0115","rachel.kingsford@hci.utah.edu",{"name":75,"role":81,"phone":85,"phoneExt":44,"email":86},"801-585-0255","naren.epperla@hci.utah.edu",[88],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Huntsman Cancer Institute at University of Utah","RECRUITING","Salt Lake City","Utah","84112","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-111.89105,40.76078,{"lat":100,"lon":99},[103],{"name":80,"role":81,"phone":82,"phoneExt":44,"email":83},{"type":105,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[107],{"name":108,"class":109},"ADC Therapeutics S.A.","INDUSTRY","100576720",false,"NCT06788964","Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)","A Phase 2 Study of Loncastuximab Tesirine and Rituximab as Bridging Therapy Prior to Standard-of-care CD19 CAR T-cell Therapy in Patients With Large B-cell Lymphoma","CORAL","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* Intended to receive commercial CD19-directed CAR-T cell therapy (axi-cel and liso-cel).\n* Need for bridging therapy as deemed clinically necessary by the treating physician.\n* Relapsed or refractory DLBCL, tFL or PMBCL as defined by the 2016 World Health Organization classification (including patients with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma (HGBL), not otherwise specified, and HGBL with MYC and BCL2 and\u002For BCL6 rearrangements.\n\n  --Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen.\n* Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT.\n* ECOG Performance Status ≤ 2.\n* Time between prior anticancer therapy and first dose of lonca-R as below\n\n  * Autologous hematopoietic cell transplantation - At least 30 days\n  * Allogeneic hematopoietic cell transplantation - At least 60 days\n  * Cytotoxic chemotherapy - At least 21 days\n  * Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n    * Platelet count ≥ 75,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    * Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and\u002F or Gilbert's disease\n    * Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 60 mL\u002Fmin by Cockcroft-Gault formula.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.41.1 and 5.4.2.\n* Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.\n* Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n* Previous treatment with any anti-CD19 therapy including lonca or prior CD19 CAR T-cell therapy\n* Subjects receiving investigational CAR-T products\n* Major surgery within 4 weeks prior to starting study therapy.\n* History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.\n* Subjects with chronic liver disease with hepatic impairment Child-Pugh class C\n* Pregnant or lactating or intending to become pregnant during the study\n* Active graft-versus-host disease\n* Post-transplantation lymphoproliferative disorders\n* Active autoimmune disease which, in the opinion of the investigator, may negatively impact subject safety or interfere with study participation.\n* The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or interfere with study participation.\n* Subjects with known CNS involvement.\n* Significant medical diseases or conditions including those requiring substantial changes in concomitant medications, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Myocardial infarction (MI) within 6 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 480 ms.\n    * Congenital long QT syndrome or a corrected QT measure (QTc) interval of \\>480 ms at screening (unless secondary to pacemaker or bundle branch block).\n  * Severe pulmonary disease\n  * Uncontrolled diabetes mellitus\n  * Severely immunocompromised state\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening\n* HIV infection.\n* Subjects with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Subjects who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing. Subjects with active Hep C patients may be enrolled if other parameters precluding hepatic impairment are met and they are not undergoing active therapy for hepatitis C.\n* Known prior severe hypersensitivity to a CD19 antibody, lonca (including SG3249) or any of its excipients, or history of positive serum human ADA to a CD19 antibody.\n* Subjects taking prohibited medications as described in Section 6.8.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.","ALL","18 Years",{"count":120,"type":121},29,"ESTIMATED","INTERVENTIONAL",[124],"PHASE2","The purpose of this clinical trial is to learn if the study treatment Loncastuximab tesirine and Rituximab is safe and efficient before standard of care chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory large B-cell lymphoma.",[127],"Relapsed or Refractory Large B-cell Lymphoma","2026-05-27",{"date":130,"type":131},"2026-05-29","ACTUAL",{"date":133,"type":131},"2025-08-25",{"date":135,"type":121},"2030-03",{"name":5,"class":6},1]