[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06343311":3,"trial-entities:NCT06343311":192,"trial-summary:NCT06343311":196},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":34,"study_type":38,"primary_purpose":39,"phases":40,"enrollment_info":43,"interventions":46,"primary_outcomes":52,"secondary_outcomes":68,"sex":97,"minimum_age":98,"maximum_age":99,"healthy_volunteers":100,"eligibility_criteria":101,"std_ages":133,"locations":136,"central_contacts":177,"overall_officials":186,"references":190,"see_also_links":191},"NCT06343311","EBUS22CD19AR100","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)","RECRUITING","2027-12-31","2025-08","2025-08-07","2024-06-01","Estrella Biopharma, Inc.","INDUSTRY",true,"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.","This is an open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety of EB103 and determine the RP2D in adult subjects (≥ 18 years of age) who have R\u002FR B-cell NHL.\n\nThe study will include a dose escalation phase followed by an expansion phase. A traditional dose escalation model (3+3 design) will be used to determine the RP2D, and once determined, the expansion phase will commence. Additional subjects will be enrolled in the expansion phase to further confirm the safety profile of EB103 at the RP2D and evaluate the preliminary efficacy of EB103.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"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",[35,23,36,26,24,27,28,37,31,32,33],"B-Cell Non-Hodgkin's Lymphoma","NHL","HIV Lymphoma","INTERVENTIONAL","TREATMENT",[41,42],"PHASE1","PHASE2",{"count":44,"type":45},21,"ESTIMATED",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51},"BIOLOGICAL","EB103","EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.",[49],[53,57,61,64],{"measure":54,"description":55,"timeFrame":56},"To assess the Dose Limiting Toxicities of EB103.","The incidence of Dose Limiting Toxicities (DLTs) that occur within 28 days following EB103 T-cell infusion will be assessed. A DLT consists of any adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, concomitant medication, or intercurrent illness that occurs within 28 days following EB103 T-cell infusion and meets specified criteria as outline in the clinical protocol. The type, frequency, and severity of each DLT, AE, and abnormal laboratory value will be documented to assess the safety and tolerability of EB103.","Time Frame: 28 days",{"measure":58,"description":59,"timeFrame":60},"Incidence rates of Treatment-Emergent Adverse Events of EB103.","The type, frequency, and severity of Treatment-Emergent Adverse Events (TEAEs) will be assessed and includes an AE that starts any time from initiation of EB103 administration through and including 90 days after EB103 administration.\n\nListing and summaries will be prepared for the following type of events: TEAEs, SAEs, Grade 3 or higher AEs, treatment related AEs (conditioning chemotherapy, protocol-mandated procedures, or EB103), and AEs leading to death. AESIs, including but not limited to acute infusion reaction, CRS, ICANS, prolonged cytopenia, TLS, MAS\u002FHLH, SPM, and hypogammaglobulinemia.","Time Frame: 90 days",{"measure":62,"description":63,"timeFrame":60},"Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.","The type, frequency, and severity after Treatment-Emergent Laboratory Abnormalities will be assessed and includes a laboratory abnormality that, compared to baseline, worsens by at least one grade with 90 days after EB103 administration.",{"measure":65,"description":66,"timeFrame":67},"To determine the Recommended Phase II Dose (RP2D) of EB103.","The RP2D will be determined by the study Dose Escalation Committee (DEC) and chosen based on the maximum tolerated dose (MTD) but will not exceed the MTD and the maximum administered dose (MAD). The RP2D will also be based on the manufacturing capability.","Time Frame: 21 months",[69,73,76,79,82,85,88,91,94],{"measure":70,"description":71,"timeFrame":72},"To assess the Overall Response Rate of EB103 in our study subject population.","The Overall Response Rate (ORR), defined as the proportion of subjects with a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) will be assessed.","Time Frame: Up to 2 years",{"measure":74,"description":75,"timeFrame":72},"To assess the Disease Control Rate of EB103 in our study subject population.","The Disease Control Rate (DCR), defined as the proportion of subjects with BOR of either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) will be assessed.",{"measure":77,"description":78,"timeFrame":72},"To assess the Duration of Response of EB103 in our study subject population.","The Duration of Response (DOR), defined as the time from first response to Progressive Disease (PD) or death will be assessed.",{"measure":80,"description":81,"timeFrame":72},"To assess the Progression-Free Survival rate of EB103 in our study subject population.","The Progression-Free Survival (PFS), defined as the time from EB103 infusion to PD or death will be assessed.",{"measure":83,"description":84,"timeFrame":72},"To assess the Event-Free Survival rate of EB103 in our study subject population.","The Event-Free Survival (EFS) will be defined as the time from EB103 T-cell infusion to the earliest of the following events: death from any cause, PD, or starting a new anticancer therapy.",{"measure":86,"description":87,"timeFrame":72},"To assess the Overall Survival rate of EB103 in our study subject population.","The Overall Survival (OS) will be defined as the time from EB103 T-cell infusion to the date of death.",{"measure":89,"description":90,"timeFrame":72},"To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax).","The peak exposure (Cmax) will be measured in our study subject population.",{"measure":92,"description":93,"timeFrame":72},"To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax).","Time to reach peak exposure (Tmax) will be measured in our study subject population.",{"measure":95,"description":96,"timeFrame":72},"To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC).","Partial area under the curve (pAUC) will be measured in our study subject population.","ALL","18 Years",null,false,{"inclusion":102,"exclusion":117,"raw_text":132},[103,104,105,106,107,108,109,110,111,112,113,114,115,116],"Age 18 years or older at the time of informed consent","Histologically confirmed R\u002FR B-cell non-Hodgkin's lymphoma (NHL)","Adequate organ function","Relapsed or refractory (R\u002FR) disease defined as ONE OR MORE of the following:","R\u002FR after ≥ 2 lines of systemic therapy","For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R\u002FR after ≥ 1 lines of systemic therapy","Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)","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","All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:","Anti-CD20 monoclonal antibody AND","An anthracycline-containing chemotherapy regimen","Positron emission tomography (PET)-positive disease according to Cheson 2014","Eastern Cooperative Oncology Group (ECOG) ≤ 2","Toxicities due to prior therapy must be stable and recovered to Grade 1 or less",[118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Prior CD19-targeted cellular therapy","History of Richter's transformation of chronic lymphocytic leukemia (CLL)","History of another primary malignancy that has not been in remission for ≥ 2 years.","History or presence of clinically relevant Central Nervous System (CNS) pathology","CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms","Subjects with active cardiac lymphoma involvement which is not responding to treatment","History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent","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.","History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years","History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents","Venous thrombosis or embolism not managed on a stable regimen of anticoagulation","Autologous HSCT within 3 months of informed consent","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","Live vaccine within 3 months prior to planned start of conditioning regimen","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",[134,135],"ADULT","OLDER_ADULT",[137,162],{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":142,"contacts":143,"geoPoint":159},"University of California, Davis","Sacramento","California","95817","United States",[144,149,153,156],{"name":145,"role":146,"phone":147,"email":148},"Richard \"RJ\" Joven, CCRP","CONTACT","916-494-2368","rmjoven@ucdavis.edu",{"name":150,"role":146,"phone":151,"email":152},"Dara Feleciano, RN, MSN","916-475-9904","djfeleciano@ucdavis.edu",{"name":154,"role":155},"Naseem Esteghamat, MD MS","PRINCIPAL_INVESTIGATOR",{"name":157,"role":158},"Mehrdad Abedi, MD","SUB_INVESTIGATOR",{"lat":160,"lon":161},38.58157,-121.4944,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":142,"contacts":167,"geoPoint":174},"Baylor Scott & White Research Institute, Texas Oncology","Dallas","Texas","75246",[168,172],{"name":169,"role":146,"phone":170,"email":171},"Philip Millsap","214-820-7381","corchemebmt@BSWHealth.org",{"name":173,"role":155},"Luis Pineiro, MD",{"lat":175,"lon":176},32.78306,-96.80667,[178,182],{"name":179,"role":146,"phone":180,"email":181},"Teresa Klask, MBA","925-949-9314","teresa.klask@eurekainc.com",{"name":183,"role":146,"phone":184,"email":185},"Pei Wang, PhD","510-654-7045","pei.wang@eurekainc.com",[187],{"name":183,"affiliation":188,"role":189},"Eureka Therapeutics Inc.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":193,"biomarkers":195},[194],"B-Cell Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":15,"summary":197,"prompt_version":207},{"design":198,"status":199,"heading":200,"summary":201,"follow_up":202,"word_count":203,"commitments":204,"compensation":205,"drugs_mentioned":206},"This is an open-label, multi-center study with a dose escalation phase followed by an expansion phase. It aims to determine the safest and most effective dose of EB103.","completed","T-Cell Therapy (EB103) for Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma","This study is testing a new T-cell therapy called EB103 for adults with B-cell non-Hodgkin's lymphoma (NHL) that has come back or not responded to previous treatments (relapsed\u002Frefractory). EB103 uses your own T-cells, which are a type of immune cell, that are specially modified to fight the cancer. The main goal of this study is to understand the safety of EB103 by looking at side effects and abnormal lab results within the first 90 days. You may be eligible if you are 18 or older, have confirmed relapsed\u002Frefractory B-cell NHL, and have adequate organ function. This study is currently enrolling about 21 participants.","The study will assess side effects and lab abnormalities for up to 90 days after treatment.",103,"Not specified in the trial record.","Not stated in the trial record.",[49],"v2"]