[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Estrella Biopharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":43,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"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":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"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",[44,32,45,35,33,36,37,46,40,41,42],"B-Cell Non-Hodgkin's Lymphoma","NHL","HIV Lymphoma","RECRUITING","2025-08-04",{"date":50,"type":51},"2025-08-07","ACTUAL",{"date":53,"type":51},"2024-06-01",{"date":55,"type":21},"2027-12-31",{"name":57,"class":58},"Estrella Biopharma, Inc.","INDUSTRY",2,""]