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Centre","Geelong","3320",{"type":79,"coordinates":341},[342,343],144.36069,-38.14711,{"lat":343,"lon":342},[346],{"name":347,"role":110,"phone":51,"phoneExt":51,"email":51},"Hannah Rose",{"type":349,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","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":359,"type":360},135,"ESTIMATED","INTERVENTIONAL",[363],"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.",[366,367,368,369],"Non-Hodgkin Lymphoma","B-cell Acute Lymphoblastic Leukemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","2026-01-28",{"date":372,"type":373},"2026-02-02","ACTUAL",{"date":375,"type":373},"2019-03-11",{"date":377,"type":360},"2027-06",{"name":5,"class":6},23]