[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576720":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":39,"enrollmentInfo":77,"targetDuration":39,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":39,"overallStatus":47,"whyStopped":39,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Utah","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: Loncastuximab Tesirine","Drug: Rituximab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"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.",[9],[22],"ZYNLONTA",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Rituximab","Rituximab is administered intravenously for 1-6 cycles (every 21 days) prior to standard of care CAR-T cell therapy.",[9],[28],"RITUXAN",[30],{"name":31,"affiliation":32,"role":33},"Narendranath Epperla, MD, MS, FACP","Huntsman Cancer Institute\u002F University of Utah","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Rachel Kingsford","CONTACT","801-585-0115",null,"rachel.kingsford@hci.utah.edu",{"name":31,"role":37,"phone":42,"phoneExt":39,"email":43},"801-585-0255","naren.epperla@hci.utah.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Huntsman Cancer Institute at University of Utah","RECRUITING","Salt Lake City","Utah","84112","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-111.89105,40.76078,{"lat":57,"lon":56},[60],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"type":62,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[64],{"name":65,"class":66},"ADC Therapeutics S.A.","INDUSTRY","100576720","phase-2-loncastuximab-tesirine-and-rituximab-as-bridging-therapy-before-standard-of-care-car-t-therapy-in-patients-with-large-b-cell-lymphoma-coral-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":78,"type":79},29,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Relapsed or Refractory Large B-cell Lymphoma","2026-05-27",{"date":88,"type":89},"2026-05-29","ACTUAL",{"date":91,"type":89},"2025-08-25",{"date":93,"type":79},"2030-03",{"name":5,"class":6},1]