[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542472":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":81,"collaborators":83,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":19,"enrollmentInfo":95,"targetDuration":19,"studyType":98,"phases":99,"briefSummary":102,"conditions":103,"keywords":119,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},{"fullName":5,"class":6},"Estrella Immunopharma, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EB103","OTHER","Approximately six (6) subjects will be treated to determine the RP2D. At the designated RP2D, approximately fifteen (15) additional subjects will be treated.",[13],"Biological: EB103",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Pei Wang, PhD","Eureka Therapeutics Inc.","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Teresa Klask, MBA","CONTACT","925-949-9314","teresa.klask@eurekainc.com",{"name":22,"role":28,"phone":32,"phoneExt":19,"email":33},"510-654-7045","pei.wang@eurekainc.com",[35,64],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of California, Davis","RECRUITING","Sacramento","California","95817","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-121.4944,38.58157,{"lat":47,"lon":46},[50,54,58,61],{"name":51,"role":28,"phone":52,"phoneExt":19,"email":53},"Richard \"RJ\" Joven, CCRP","916-494-2368","rmjoven@ucdavis.edu",{"name":55,"role":28,"phone":56,"phoneExt":19,"email":57},"Dara Feleciano, RN, MSN","916-475-9904","djfeleciano@ucdavis.edu",{"name":59,"role":60,"phone":19,"phoneExt":19,"email":19},"Naseem Esteghamat, MD MS","PRINCIPAL_INVESTIGATOR",{"name":62,"role":63,"phone":19,"phoneExt":19,"email":19},"Mehrdad Abedi, MD","SUB_INVESTIGATOR",{"facility":65,"status":37,"city":66,"state":67,"zip":68,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Baylor Scott & White Research Institute, Texas Oncology","Dallas","Texas","75246",{"type":44,"coordinates":70},[71,72],-96.80667,32.78306,{"lat":72,"lon":71},[75,79],{"name":76,"role":28,"phone":77,"phoneExt":19,"email":78},"Philip Millsap","214-820-7381","corchemebmt@BSWHealth.org",{"name":80,"role":60,"phone":19,"phoneExt":19,"email":19},"Luis Pineiro, MD",{"type":82,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[84],{"name":23,"class":6},"100542472","phase-1-t-cell-therapy-eb103-in-adults-with-relapsedrefractory-b-cell-non-hodgkins-lymphoma-nhl-100542472",false,"NCT06343311","T-Cell Therapy (EB103) in Adults With Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (NHL)","An Open-Label, Dose Escalation, Multi-Center Phase I\u002FII Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed\u002FRefractory (R\u002FR) B-Cell Non-Hodgkin's Lymphoma (NHL)","STARLIGHT-1","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent\n* Histologically confirmed R\u002FR B-cell non-Hodgkin's lymphoma (NHL)\n* Adequate organ function\n* Relapsed or refractory (R\u002FR) disease defined as ONE OR MORE of the following:\n\n  * R\u002FR after ≥ 2 lines of systemic therapy\n\n    * For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R\u002FR after ≥ 1 lines of systemic therapy\n  * Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)\n  * For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens\n* All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:\n\n  * Anti-CD20 monoclonal antibody AND\n  * An anthracycline-containing chemotherapy regimen\n* Positron emission tomography (PET)-positive disease according to Cheson 2014\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Toxicities due to prior therapy must be stable and recovered to Grade 1 or less\n\nExclusion Criteria:\n\n* Prior CD19-targeted cellular therapy\n* History of Richter's transformation of chronic lymphocytic leukemia (CLL)\n* History of another primary malignancy that has not been in remission for ≥ 2 years.\n* History or presence of clinically relevant Central Nervous System (CNS) pathology\n* CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms\n* Subjects with active cardiac lymphoma involvement which is not responding to treatment\n* History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent\n* Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n* History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years\n* History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents\n* Venous thrombosis or embolism not managed on a stable regimen of anticoagulation\n* Autologous HSCT within 3 months of informed consent\n* Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening\n* Live vaccine within 3 months prior to planned start of conditioning regimen","ALL","18 Years",{"count":96,"type":97},21,"ESTIMATED","INTERVENTIONAL",[100,101],"PHASE1","PHASE2","This is an open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed\u002Frefractory (R\u002FR) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.",[104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"B-Cell Non-Hodgkin's Lymphoma (NHL)","Lymphoma, Non-Hodgkins","Lymphomas Non-Hodgkin's B-Cell","Non-Hodgkin Lymphoma","Non-Hodgkin's Lymphoma","Large B-Cell Lymphoma","Lymphoma, Non-Hodgkin's, Adult","Lymphoma","Refractory Non-Hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","Lymphoma, Non-Hodgkin","HIV Associated Lymphoma","CNS Lymphoma","High-grade B-cell Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma",[120,108,121,111,109,112,113,122,116,117,118],"B-Cell Non-Hodgkin's Lymphoma","NHL","HIV Lymphoma","2025-08-04",{"date":125,"type":126},"2025-08-07","ACTUAL",{"date":128,"type":126},"2024-06-01",{"date":130,"type":97},"2027-12-31",{"name":132,"class":6},"Estrella Biopharma, Inc.",2]