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    DRUG:

    azercabtagene zapreleucel (PBCAR0191)

    i
    Other names: PBCAR0191, PBCAR-0191, PBCAR 0191, allogeneic anti-CD19 CAR T cells, azer-cel
    Company:
    Imugene, Precision BioSci, TG Therap
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    1m
    A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, TG Therapeutics, Inc.
    New P1 trial
    |
    azercabtagene zapreleucel (PBCAR0191)
    5ms
    Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies (clinicaltrials.gov)
    P1, N=13, Completed, Precision BioSciences, Inc. | Recruiting --> Completed | N=24 --> 13
    Trial completion • Enrollment change
    |
    CD19 (CD19 Molecule)
    |
    azercabtagene zapreleucel (PBCAR0191) • PBCAR19B
    6ms
    PBCAR0191-01: Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients With r/r NHL and r/r B-cell ALL (clinicaltrials.gov)
    P1, N=129, Recruiting, Imugene Limited | Trial completion date: Mar 2028 --> Jun 2027 | Trial primary completion date: Mar 2026 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    |
    cyclophosphamide • bendamustine • fludarabine IV • azercabtagene zapreleucel (PBCAR0191)
    6ms
    PBCAR0191-01: Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients With r/r NHL and r/r B-cell ALL (clinicaltrials.gov)
    P1, N=129, Recruiting, Imugene Limited | Phase classification: P1/2 --> P1 | Trial completion date: Jun 2024 --> Mar 2028 | Trial primary completion date: Mar 2024 --> Mar 2026
    Phase classification • Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    |
    cyclophosphamide • bendamustine • fludarabine IV • azercabtagene zapreleucel (PBCAR0191)
    12ms
    PBCAR0191-01: Dose-escalation, Dose-expansion Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL (clinicaltrials.gov)
    P1/2, N=120, Recruiting, Imugene Limited
    Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    |
    cyclophosphamide • fludarabine IV • azercabtagene zapreleucel (PBCAR0191)
    2years
    Effective Cell Dose and Functional Attributes of Azercabtagene Zapreleucel (azer-cel; PBCAR0191) Associate with Allogeneic CAR T-Cell Safety and Efficacy in Patients with Relapsed/Refractory B-Cell Lymphoma (ASH 2022)
    Azer-cel was administered as a single infusion to 44 subjects across several dose levels and fludarabine/cyclophosphamide lymphodepletion regimens. Post-thaw product composition and effective cell dose are predictive for in vivo expansion potential, CAR-T-related adverse events and response to treatment with azer-cel. This is the first analysis of an allogeneic CD19 CAR T product composition to demonstrate that strategies intended to maximize stem central memory T-cell fraction (CCR7+) while limiting CD4+ CCR7- differentiated fraction may improve safety and efficacy of CAR T therapy.
    Clinical • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • CCR7 (Chemokine (C-C motif) receptor 7)
    |
    cyclophosphamide • fludarabine IV • azercabtagene zapreleucel (PBCAR0191)
    over2years
    PBCAR0191-01: Dose-escalation, Dose-expansion Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL (clinicaltrials.gov)
    P1/2, N=120, Recruiting, Precision BioSciences, Inc. | N=92 --> 120 | Trial completion date: Jun 2022 --> Jun 2024 | Trial primary completion date: Feb 2022 --> Dec 2023
    Enrollment change • Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule) • CRP (C-reactive protein)
    |
    cyclophosphamide • fludarabine IV • azercabtagene zapreleucel (PBCAR0191)
    over3years
    PBCAR0191-01: Dose-escalation Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL (clinicaltrials.gov)
    P1/2, N=92, Recruiting, Precision BioSciences, Inc. | Trial completion date: Oct 2021 --> Jun 2022 | Trial primary completion date: Oct 2021 --> Feb 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • fludarabine IV • azercabtagene zapreleucel (PBCAR0191)
    over4years
    Dose-escalation Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL (clinicaltrials.gov)
    P1/2, N=92, Recruiting, Precision BioSciences, Inc. | Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jul 2020 --> Oct 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    fludarabine IV • azercabtagene zapreleucel (PBCAR0191)
    5years
    Initial Findings of the Phase 1 Trial of PBCAR0191, a CD19 Targeted Allogeneic CAR-T Cell Therapy (ASH 2019)
    Lymphodepletion was administered on day -5 to day -3 using fludarabine 30mg/m2/day and cyclophosphamide 500mg/m2/day...One patient enrolled post disease progression after treatment with Axicabtagene ciloleucel... Further enrollment of patients into DL2 is ongoing. Data from DL2 entered by early October will be included in a presentation in the meeting. Findings to date indicate preliminary evidence of short-lived cell-mediated anti-tumor effect and preliminary evidence of cell expansion in vivo, which will be evaluated more fully at DL2 and DL3.
    P1 data • CAR T-Cell Therapy • IO biomarker
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6)
    |
    Yescarta (axicabtagene ciloleucel) • fludarabine IV • azercabtagene zapreleucel (PBCAR0191)