[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Imugene Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100336867","phase-1-dose-escalation-and-dose-expansion-study-of-safety-of-azer-cel-pbcar0191-in-participants-with-relapsedrefractory-rr-non-hodgkin-lymphoma-nhl-and-rr-b-cell-acute-lymphoblastic-leukemia-b-all-100336867",false,"NCT03666000","Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed\u002FRefractory (r\u002Fr) Non-Hodgkin Lymphoma (NHL) and r\u002Fr B-cell Acute Lymphoblastic Leukemia (B-ALL)","A Phase 1\u002F1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 (Azercabtagene Zapreleucel or \"Azer-cel\") in Subjects With Relapsed\u002FRefractory (r\u002Fr) Non-Hodgkin Lymphoma (NHL) and r\u002Fr B-cell Acute Lymphoblastic Leukemia (B-ALL)","Key Inclusion Criteria\n\nCriteria for B-ALL:\n\n• Participant has confirmed unequivocal r\u002Fr CD19+ B-ALL.\n\nCriteria for NHL and CLL\u002FSLL:\n\n• Participant has unequivocal aggressive CD19+ r\u002Fr B-cell NHL that is confirmed by tumor biopsy tissue from last relapse after CD19-directed therapy.\n\nFor Phase 1 Dose Escalation:\n\n* Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation\n* Follicular lymphoma (FL) including Grade 3 or transformed FL\n* High-grade B-cell lymphoma (HGBCL)\n* Primary mediastinal lymphoma\n\nFor Phase 1b Dose Expansion (CAR T-relapsed cohort):\n\n* DLBCL not otherwise specified (NOS)\n* HGBCL\n* DLBCL transformed from the following indolent lymphoma subtypes (FL, Marginal Zone lymphoma \\[MZL\\], and Waldenstrom's Macroglobulinemia \\[WM\\])\n* Other large B-cell lymphoma (LBCL) subtypes may be enrolled with approval from the Medical Monitor.\n* Participants previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product.\n* For the expansion CAR T-relapsed cohort only: Participants must have received autologous CD19-directed CAR T therapy and demonstrated clinical response to the treatment at Day 28 or later, followed by relapse or progression.\n\nFor Phase 1b dose expansion (CAR T-naive cohort):\n\n* DLBCL NOS\n* DLBCL transformed from the following indolent lymphoma subtypes (FL, MZL, and WM)\n* HGBCL\n* FL (Grade 1-3a)\n* MZL that is fluorodeoxyglucose (FDG)-avid on positron emission tomography (PET) scan\n* WM\n* CLL\u002FSLL\n* Primary central nervous system (CNS) lymphoma (PCNSL)\n* Other LBCL subtypes may be enrolled with approval from the Medical Monitor.\n* Participant must have received at least 1-2 prior lines of therapy, depending on histological subtype but no more than 7 systemic lines of anti-cancer therapy.\n\nCriteria for both B-ALL, NHL, and CLL\u002FSLL:\n\n* Eastern Cooperative Oncology Group performance status score of 0 or 1.\n* An estimated life expectancy of at least 12 weeks according to the investigator's judgment.\n* Seronegative for human immunodeficiency virus antibody.\n* Participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.\n\nKey Exclusion Criteria\n\nCriteria for B-ALL:\n\n• Burkitt cell (L3 ALL) or mixed-lineage acute leukemia.\n\nCriteria for NHL:\n\n* Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.\n* Active hemolytic anemia.\n\nCriteria for B-ALL and NHL:\n\n* No active CNS disease, excluding PCNSL\n* History of another primary malignancy\n* Any form of primary immunodeficiency (for example, severe combined immunodeficiency disease).\n* History of hepatitis B or hepatitis C currently receiving ongoing antiviral therapy.\n\nAny known uncontrolled cardiovascular disease at the time of Screening that, in the investigator's opinion, renders the participant ineligible\n\n* History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Presence of a CNS disorder that, in the opinion of the investigator, renders the participant ineligible for treatment.\n* History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome.\n* Active uncontrolled autoimmune disease requiring active immunosuppression at the time of Screening (excluding participants needing steroids for physiologic replacement).\n* Participant has received stem cell transplant within 90 days before Screening.\n* Participant has active graft-versus-host disease (GvHD) symptoms.\n* Participant has received a systemic biologic agent for treatment of the disease under study within 28 days of LD, other systemic anti-cancer therapy within 10 days or 5 half-lives (whichever is shorter) of LD, and no pulse steroid for disease control within 3 days of LD.\n* Radiotherapy within 4 weeks before Screening.\n* Presence of pleural\u002Fperitoneal\u002Fpericardial catheter, as well as permeant biliary and ureteral stents (does not apply to intravenous lines).\n* Participant has received live vaccine within 4 weeks before Screening. Note: Non-live virus vaccines are not excluded.\n* Participant has received CD19-directed therapy other than autologous CD19-directed CAR T therapy within 90 days of the anticipated start date of LD.\n\nAdditional criteria apply.","ALL","18 Years",{"count":19,"type":20},135,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1\u002F1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r\u002Fr B ALL, r\u002Fr B-cell NHL and CLL\u002FSLL.",[26,27,28,29],"Non-Hodgkin Lymphoma","B-cell Acute Lymphoblastic Leukemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","RECRUITING","2026-01-28",{"date":33,"type":34},"2026-02-02","ACTUAL",{"date":36,"type":34},"2019-03-11",{"date":38,"type":20},"2027-06",{"name":40,"class":41},"Imugene Limited","INDUSTRY",23,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100502451","long-term-follow-up-of-study-participants-who-received-an-allogeneic-chimeric-antigen-receptor-t-cell-product-in-an-imugene-ltd-clinical-study-100502451","NCT05822427","Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study","Inclusion Criteria:\n\n* Receipt of at least 1 dose of azer-cel in an Imugene clinical study.\n* A signed informed consent form (ICF).\n* Willingness and ability to adhere to the study schedule and all other protocol requirements.\n\nExclusion Criteria:\n\n* No unique exclusion criteria apply to this study.",{"count":50,"type":20},75,"OBSERVATIONAL","The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:\n\n* What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?\n* What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?\n\nParticipants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.",[54],"Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study",[56,57],"Allogeneic chimeric antigen receptor (CAR) T cell products","azer-cel","2025-05-11",{"date":60,"type":34},"2025-05-14",{"date":62,"type":34},"2020-08-25",{"date":64,"type":20},"2039-12",{"name":40,"class":41},1,""]