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    DRUG:

    ulviprubart (ABC008)

    i
    Other names: ABC008, ABC-008
    Associations

    News

    Trials
    Company:
    Abcuro
    Drug class:
    KLRG1 depleter
    Associations

    News

    Trials
    25d
    A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis (clinicaltrials.gov)
    P2/3, N=272, Completed, Abcuro, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    ulviprubart (ABC008)
    1year
    A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients with (IBM) (clinicaltrials.gov)
    P1, N=19, Completed, Abcuro, Inc. | Active, not recruiting --> Completed | N=30 --> 19 | Trial completion date: Aug 2025 --> Jan 2025
    Trial completion • Enrollment change • Trial completion date
    |
    ulviprubart (ABC008)
    1year
    Long-term Extension Study of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis (clinicaltrials.gov)
    P2/3, N=270, Active, not recruiting, Abcuro, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ulviprubart (ABC008)
    over1year
    ABC008 in Subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL) (clinicaltrials.gov)
    P1/2, N=21, Active, not recruiting, Abcuro, Inc. | Recruiting --> Active, not recruiting | N=30 --> 21 | Trial completion date: Dec 2025 --> Sep 2027 | Trial primary completion date: Dec 2024 --> Sep 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    ulviprubart (ABC008)
    over1year
    Long-term Extension Study of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis (clinicaltrials.gov)
    P2/3, N=270, Recruiting, Abcuro, Inc. | Not yet recruiting --> Recruiting | Trial primary completion date: Aug 2028 --> Jan 2029
    Enrollment open • Trial primary completion date
    |
    ulviprubart (ABC008)
    over1year
    Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis (clinicaltrials.gov)
    P2/3, N=270, Not yet recruiting, Abcuro, Inc.
    New P2/3 trial
    |
    ulviprubart (ABC008)
    over1year
    A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM) (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Abcuro, Inc. | Trial completion date: May 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    ulviprubart (ABC008)
    2years
    A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis (clinicaltrials.gov)
    P2/3, N=231, Recruiting, Abcuro, Inc.
    Trial completion date • Trial primary completion date
    |
    ulviprubart (ABC008)
    2years
    A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM) (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Abcuro, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ulviprubart (ABC008)
    over2years
    ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL) (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Abcuro, Inc. | N=15 --> 30 | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    KLRG1 (Killer Cell Lectin Like Receptor G1)
    |
    KLRG1 expression
    |
    ulviprubart (ABC008)
    over3years
    KLRG1 Depletion Is a Novel Therapeutic Strategy for Patients with Mature T and NK/T-Cell Lymphomas (ASH 2022)
    Duvelisib (Duv), a dual PI3K-δ/γ inhibitor (PI3Ki), has demonstrated a high ORR of 50% in phase II trials in TCLs and its ability to reprogram macrophages to an M1 phenotype in TCL PDXs. Selective depletion of tumor cells with an anti-KLRG1 depleting mAb in specific subtypes of TCLs, T-LGLL, and CLPD-NK is effective in vitro and in vivo, and its combination with Duv has marked activity in an aggressive PTCL-NOS xenograft model. A multicenter phase I/II trial of the KLRG1 depleting antibody ABC008 (Abcuro) in patients with R/R T-LGLL has been initiated.
    Clinical
    |
    CD8 (cluster of differentiation 8) • NCAM1 (Neural cell adhesion molecule 1) • TP63 (Tumor protein 63) • KLRG1 (Killer Cell Lectin Like Receptor G1) • B3GAT1 (Beta-1,3-Glucuronyltransferase 1)
    |
    KLRG1 expression
    |
    Copiktra (duvelisib) • ulviprubart (ABC008)
    over3years
    ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL) (clinicaltrials.gov)
    P1/2, N=15, Recruiting, Abcuro, Inc.
    New P1/2 trial
    |
    KLRG1 (Killer Cell Lectin Like Receptor G1)
    |
    KLRG1 expression
    |
    ulviprubart (ABC008)