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    DRUG:

    bbT369

    i
    Other names: bbT369
    Associations

    News

    Trials
    Company:
    Regeneron
    Drug class:
    CD20-targeted CAR-T immunotherapy, CD79a-targeted CAR-T immunotherapy
    Related drugs:
    Associations

    News

    Trials
    1m
    CRC-403: A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=50, Recruiting, 2seventy bio | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial primary completion date • CAR T-Cell Therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    bbT369
    1year
    bbT369, a Clinical-Stage Dual-Targeted and CBLB Gene Edited Autologous CAR T Product for Non-Hodgkin Lymphoma, Shows Edit Driven Enhanced Activity in Preclinical In Vitro and In Vivo Models (ASGCT 2023)
    In addition, we show that bbT369 T cells drive greater T cell expansion and durable tumor control compared with unedited controls in vivo using a xenograft NSG mouse model. Collectively, the data support the potential for bbT369 to provide deeper and more durable responses in NHL patients including those with more challenging disease characteristics.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CBL (Cbl proto-oncogene) • CD79A (CD79a Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • CBLB (Cbl Proto-Oncogene B)
    |
    CD20 expression
    |
    bbT369
    over1year
    CRC-403: A Phase 1/2 Study of bbT369, a Dual CD79a and CD20 Targeting CAR T Cell Drug Product with a Gene Edit, in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (ASH 2022)
    The starting dose of bbT369 is 50x106 CAR+ T cells and a BOIN design is being used for dose escalation/de-escalation decisions during the study. Upon establishment of the RP2D, the phase 2 portion will begin enrollment.
    P1/2 data • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule) • CD79A (CD79a Molecule)
    |
    bbT369
    2years
    bbT369, a dual-targeted and CBLB gene-edited autologous CART product, demonstrates anti-lymphoma activity in preclinical mouse models (AACR 2022)
    Furthermore, while a fraction of mice (3/5) receiving the unedited anti-CD79a/CD20 dual-targeting CAR T cells experienced late relapses (between 60-80 days following initial tumor clearance), all mice (n=5) receiving bbT369 were fully protected from late relapses (up to day 104 of follow-up). Collectively, the data support a first-in-human trial for bbT369 to evaluate initial safety and efficacy in NHL patients.
    Preclinical • IO biomarker
    |
    CBL (Cbl proto-oncogene)
    |
    CD20 expression
    |
    bbT369
    2years
    A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=50, Recruiting, 2seventy bio | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    bbT369
    over2years
    A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, 2seventy bio
    New P1/2 trial • CAR T-Cell Therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    bbT369