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    DRUG:

    AZD0486

    i
    Other names: AZD0486, TNB-486
    Associations

    News

    Trials
    Company:
    Ancora Biotech, AstraZeneca
    Drug class:
    CD3 agonist, CD19 inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients (clinicaltrials.gov)
    P3, N=1005, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • AZD0486
    3ms
    Soundtrack-E: A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies (clinicaltrials.gov)
    P1/2, N=180, Not yet recruiting, AstraZeneca
    New P1/2 trial • Combination therapy
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib) • vincristine • prednisone • AZD0486
    3ms
    A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients (clinicaltrials.gov)
    P3, N=1005, Not yet recruiting, AstraZeneca
    New P3 trial
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • AZD0486
    4ms
    D7400C00006: A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=116, Recruiting, AstraZeneca | N=206 --> 116
    Enrollment change
    |
    AZD0486
    4ms
    AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL (clinicaltrials.gov)
    P2, N=240, Not yet recruiting, AstraZeneca
    New P2 trial
    |
    AZD0486
    6ms
    D7400C00006: A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=206, Recruiting, AstraZeneca | N=116 --> 206
    Enrollment change
    |
    CD19 positive
    |
    AZD0486
    10ms
    AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia (clinicaltrials.gov)
    P1/2, N=120, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    AZD0486
    11ms
    D7400C00006: A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=116, Recruiting, AstraZeneca | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    CD19 positive
    |
    AZD0486
    12ms
    AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia (clinicaltrials.gov)
    P1/2, N=120, Not yet recruiting, AstraZeneca
    New P1/2 trial
    |
    AZD0486
    1year
    A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=116, Recruiting, AstraZeneca | Trial completion date: May 2024 --> Oct 2025 | Trial primary completion date: Aug 2023 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    CD19 positive
    |
    AZD0486
    1year
    Double Step-up Dosing (2SUD) Regimen Mitigates Severe Icans and CRS While Maintaining High Efficacy in Subjects with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (NHL) Treated with AZD0486, a Novel CD19xCD3 T-Cell Engager (TCE): Updated Safety and Efficacy Data from the Ongoing First-in-Human (FIH) Phase 1 Trial (ASH 2023)
    AZD0486 (formerly TNB-486) is an active treatment in patients with advanced R/R B-NHL and has a predictable safety profile characterized by mainly low-grade AEs and fully transient and reversible CRS/ICANS events. The 2 SUD schedule reduced the overall rate of low grade CRS and ICANS (Grade 1-2) and abrogated Grade 3 events further improving the risk/benefit profile of AZD0486. Dose escalation is ongoing to identify the RP2D.
    Clinical • P1 data
    |
    CD20 (Membrane Spanning 4-Domains A1) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL10 (Interleukin 10)
    |
    CD20 negative
    |
    AZD0486
    over1year
    PHASE II STUDY OF GLOFITAMAB, POSELTINIB AND LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE B CELL LYMPHOMAS (EHA 2023)
    Background: Despite the groundbreaking introduction of rituximab for the treatment of diffuse large B cell lymphoma (DLBCL), approximately 30% of the patients ultimately experience refractory / relapse (R/R) disease and so far myriads attempts to improve survival outcomes have not yielded firm positive results...To mitigate the risk of glofitamab associated cytokine release syndrome, obinutuzumab premedication and cycle 1 step-up dosing was implemented...One patient with a previous history of prior COVID19 infection after TNB-486 (CD19/CD3 bispecific) clinical trial, despite receiving vaccination prior to this study enrollment, experienced COVID19 reactivation after cycle 1... Glofitamab, poseltinib and lenalidomide (GPL) is promising combination for thetreatment of R/R DLBCL. (Table) Refractory, DLBCL, Bispecific
    Clinical • P2 data
    |
    BCL6 (B-cell CLL/lymphoma 6)
    |
    CD20 positive
    |
    Rituxan (rituximab) • lenalidomide • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm) • AZD0486 • poseltinib (HM71224)
    over1year
    HIGH COMPLETE RESPONSE RATE WITH TNB-486, A NOVEL CD19XCD3 T-CELL ENGAGER, IN RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA: INTERIM RESULTS FROM AN ONGOING PHASE 1 STUDY (EHA 2023)
    TNB-486 induces high complete remission rates during early phase dose escalation. With limited follow-up, responses appear durable in heavily pretreated FL pts, with a manageable safety profile. Dose escalation is ongoing to identify the RP2D.
    Clinical • P1 data
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression • CD20 negative
    |
    AZD0486