^
    over1year
    Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*) (clinicaltrials.gov)
    P1, N=69, Recruiting, Minerva Biotechnologies Corporation | Trial primary completion date: Jan 2023 --> Jan 2025
    Trial primary completion date • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MUC1 (Mucin 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR negative • ER negative • MUC1 expression • HR positive + HER-2 negative
    |
    huMNC2-CAR22 • huMNC2-CAR44 CAR T cells
    over2years
    Phase I/II first-in-human CAR T–targeting MUC1 transmembrane cleavage product (MUC1*) in patients with metastatic breast cancer. (ASCO 2022)
    huMNC2-CAR44 T cells completely obliterated a variety of MUC1* positive solid tumors in NSG mice in vivo...Dose escalation is standard 3+3 design with dosing levels ranging from 3.3x10^5 to 1.0x10^7 CAR+ cells/kg, and fludarabine/cyclophosphamide lymphodepletion pre-treatment...Six (6) patients have been enrolled and five (5) patients have been treated to date. Phase II will be comprised of 3 cohorts of 15 patients in each arm of luminal, HER2+ and triple negative breast cancers for a total of 45 patients in Phase II.
    Clinical • P1/2 data • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • MUC1 (Mucin 1)
    |
    MUC1 expression
    |
    cyclophosphamide • fludarabine IV • huMNC2-CAR44 CAR T cells
    almost3years
    Autologous huMNC2-CAR44 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*) (clinicaltrials.gov)
    P1, N=69, Recruiting, Minerva Biotechnologies Corporation | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MUC1 (Mucin 1)
    |
    HER-2 positive • HR positive • HER-2 negative • MUC1 expression • HR positive + HER-2 negative
    |
    huMNC2-CAR44 CAR T cells
    over3years
    Autologous huMNC2-CAR44 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*) (clinicaltrials.gov)
    P1, N=69, Active, not recruiting, Minerva Biotechnologies Corporation | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MUC1 (Mucin 1)
    |
    HER-2 positive • HR positive • HER-2 negative • MUC1 expression • HR positive + HER-2 negative
    |
    huMNC2-CAR44 CAR T cells
    over3years
    [VIRTUAL] Phase I study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express a chimeric antigen receptor, huMNC2-CAR44 specific for a cleaved form of MUC1 (MUC1*). (ASCO 2021)
    Lymphodepletion with cyclophosphamide and fludarabine is followed by infusion of huMNC2-CAR44 CAR-T cells in escalating doses (3.3 x 105 CAR+ T cells/kg – 1 x 107 CAR+ T cells/kg) . Study is open to screening and enrollment in dose escalation . Up to 69 patients may be enrolled in dose escalation and expansion phases.
    P1 data • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    HER-2 positive • HER-2 expression • MUC1 expression
    |
    fludarabine IV • huMNC2-CAR44 CAR T cells
    over3years
    [VIRTUAL] First-in-human CAR T targets MUC1 transmembrane cleavage product (AACR 2021)
    We incorporated one of these cancer-specific antibodies into a CAR T. huMNC2-CAR44 is in a 1st-in-human clinical trial [NCT04020575] for metastatic breast cancers, currently being performed at the Fred Hutchinson Cancer Research Center... MUC1* is the predominant form of MUC1 on cancerous tissues. Antibodies that bind to a specific conformation within the ectopic growth factor binding site in the MUC1* extra cellular domain are tumor selective. CAR T cells incorporating these antibodies are highly effective against solid tumors in animals.
    P1 data
    |
    CD8 (cluster of differentiation 8) • MUC1 (Mucin 1)
    |
    MUC1 expression
    |
    huMNC2-CAR44 CAR T cells
    almost5years
    Autologous huMNC2-CAR44 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*) (clinicaltrials.gov)
    P1, N=69, Recruiting, Minerva Biotechnologies Corporation | Trial completion date: Sep 2023 --> Jan 2035 | Initiation date: Sep 2019 --> Jan 2020 | Trial primary completion date: Sep 2022 --> Jan 2023
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MUC1 (Mucin 1)
    |
    HER-2 positive • HR positive • MUC1 expression
    |
    huMNC2-CAR44 CAR T cells