[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lyell Immunopharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":139},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,91],{"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":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100463793","phase-1-lyl273-for-patients-with-relapsed-or-refractory-mcrc-100463793",false,"NCT05319314","LYL273 for Patients With Relapsed or Refractory mCRC","A Phase 1\u002F2 Multicenter Study Evaluating the Safety and Efficacy of LYL273 in Patients With Relapsed or Refractory Metastatic Colorectal Cancer","CARABiNER","Inclusion Criteria:\n\n* Adults \\> 18 years old\n* Clinical and histopathological diagnosis of relapsed or refractory metastatic colorectal cancer\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)\n* No surgical options with curative intent\n* Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy\n* Have at least one extracranial measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 standard\n\nExclusion Criteria:\n\n* Participants with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive tract, urinary bladder, or blood vessel) with LYL273 therapy\n* Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT)\n* History of or active viral infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement in the 2-year period leading up to the study enrollment\n* No active infectious diseases or comorbid conditions that would interfere with safety or data quality\n* Pregnant or breast-feeding women\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years",{"count":20,"type":21},155,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase 1\u002F2 open-label, multicenter study evaluating the safety and efficacy of LYL273 in participants with relapsed or refractory metastatic colorectal cancer.",[28],"Colorectal Cancer",[30,31,32,33,34,35,36,37,38,39,40],"relapsed metastatic colorectal cancer","refractory metastatic colorectal cancer","chimeric antigen receptors (CAR)","colorectal cancer","metastatic colorectal cancer","mCRC","CAR T-cell","guanylyl cyclase C","GCC","colorectal neoplasms","autologous T cells","RECRUITING","2026-06-05",{"date":44,"type":45},"2026-06-09","ACTUAL",{"date":47,"type":45},"2022-08-01",{"date":49,"type":21},"2032-06",{"name":51,"class":52},"Lyell Immunopharma, Inc.","INDUSTRY",4,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":77,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100607438","phase-3-a-study-to-investigate-ronde-cel-versus-investigators-choice-cd19-car-t-cell-therapy-100607438","NCT07188558","A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19\u002FCD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","PiNACLE-H2H","Key Inclusion Criteria:\n\n1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy\n2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Transformations of indolent B-cell lymphomas (excluding Richter's transformation)\n   * DLBCL\u002FHigh-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements\n   * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Grade 3B follicular lymphoma\u002Flarge cell follicular lymphoma (FL3B)\n3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy\n4. Measurable disease by presence of \\[18F\\]-fluorodeoxyglucose PET\u002FCT positive lesion during Screening per Lugano Criteria\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria:\n\n1. Patients ineligible to receive CD19 CAR T-cell therapy\n2. Primary CNS lymphoma\n3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (Richter's transformation)\n4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years\n5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment\n6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":63,"type":21},400,[65],"PHASE3","This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19\u002FCD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.",[68,69,70,71,72,73,74,75,76],"Large B-cell Lymphoma","Lymphoma, B-Cell","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma Refractory\u002F Relapsed","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[78,72,79,80,81,68],"Lymphoma","CAR T-Cell Therapy","CD19","CD19\u002FCD20","2026-06-04",{"date":84,"type":45},"2026-06-08",{"date":86,"type":45},"2026-01-12",{"date":88,"type":21},"2032-01",{"name":51,"class":52},38,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100502767","phase-1-study-of-rondecabtagene-autoleucel-in-aggressive-large-b-cell-lymphoma-100502767","NCT05826535","Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma","A Phase 1\u002F2 Multi-Center Study Evaluating the Safety and Efficacy of Rondecabtagene Autoleucel, a CD19\u002FCD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Willing and able to provide written informed consent\n3. Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)\n4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3\n5. Relapsed or refractory disease.\n6. At least 1 measurable lesion (per Lugano classification)\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)\n8. Absolute neutrophil count (ANC) ≥ 1000\u002FµL\n9. Platelet count ≥ 50,000\u002FµL\n10. Absolute lymphocyte count (ALC) ≥ 200\u002FµL\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years\n2. Active central nervous system involvement\n3. History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma\n4. Ongoing or impending oncologic emergency\n5. Recent systemic anti-cancer therapy or radiation\n6. Ongoing non-hematologic toxicities due to prior therapy\n7. History of allogeneic stem cell or solid organ transplantation\n8. Autologous stem cell transplantation within 6 weeks\n9. History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).\n10. Primary immunodeficiency\n11. History of autoimmune disease resulting in end organ injury or requiring recent therapy\n\nOther protocol-defined criteria apply.",{"count":99,"type":21},270,[24,25],"This is a Phase 1\u002F2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.",[70,71,72,68],[36,72,104,80,105,106,107,108,109,110,111,112,113,114,115,116,117,118,78,119,120,121,122,123,124,125,126,127,128,129],"CD19\u002F20","CD20","NHL","Diffuse Large B-cell lymphoma","DLBCL","Transformed follicular lymphoma","TFL","Primary mediastinal B-cell lymphoma","PMBCL","Follicular lymphoma Grade 3B","Large cell follicular lymphoma","Aggressive B-cell NHL","Refractory Aggressive B-Cell Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma","Lymphoma, Non-Hodgkin","Lymphoma, Large B-Cell, Diffuse","Cyclophosphamide","Fludarabine","Lymphoma, Follicular","Lymphoma, B-cell","Immunosuppressive Agents","Immunologic Factors","Disease Attributes","Immune System Diseases","Recurrence","PiNACLE","2026-05-26",{"date":132,"type":45},"2026-05-28",{"date":134,"type":45},"2023-05-09",{"date":136,"type":21},"2031-06-30",{"name":51,"class":52},34,""]