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    2ms
    Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1, N=25, Recruiting, Biohaven Pharmaceuticals, Inc. | Trial completion date: Oct 2026 --> Dec 2024 | Trial primary completion date: Oct 2025 --> Dec 2024
    Trial completion date • Trial primary completion date • Minimal residual disease
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    CD34 (CD34 molecule)
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    BHV-1100
    1year
    Expansion, Persistence, and Characteristics of Autologous, Bhv-1100 Armored Memory-like NK Cells Infused Prior to Autologous Stem Cell Transplant in MRD+ Multiple Myeloma Patients: A First-in-Human Trial (ASH 2023)
    CIML NK cells were manufactured with a 100% success rate and infused at a target dose of 5-10x106 cells/kg-body weight, 24 hours after 200 mg/m2 melphalan administration. Regulatory T cells increased by D+7 (3% vs 15% total PBMC) and returned to baseline after D+14 most likely reflecting the effect of IL-2 treatment. The functional capacity of the infused product was tested in vitro
    Clinical • P1 data • IO biomarker
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    NCAM1 (Neural cell adhesion molecule 1) • IL18 (Interleukin 18) • IL15 (Interleukin 15) • B3GAT1 (Beta-1,3-Glucuronyltransferase 1) • KLRC1 (Killer Cell Lectin Like Receptor C1)
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    NCAM1 positive
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    melphalan • BHV-1100 • CIML NK
    over1year
    Expansion, persistence, and characteristics of autologous, BHV-1100 ARMored memory-like NK cells infused prior to autologous stem cell transplant in MRD+, newly diagnosed multiple myeloma patients (IMW 2023)
    The product was infused fresh on D0 after standard melphalan 200 mg/m2 myeloablative conditioning and followed by stem cells infusion. This is an ongoing trial (NCT04634435) with a median follow-up of 191 days. We are herein reporting data on in vivo expansion and functional characterization of ARMored CIML NK for the first 4 patients. CIML NK cells were manufactured with a 100% success rate and infused at a target dose of 5-10x106 cells.
    Clinical • IO biomarker
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    IL18 (Interleukin 18) • IL15 (Interleukin 15) • B3GAT1 (Beta-1,3-Glucuronyltransferase 1) • KLRC1 (Killer Cell Lectin Like Receptor C1)
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    melphalan • BHV-1100
    over1year
    Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1, N=25, Recruiting, Biohaven Pharmaceuticals, Inc. | Trial primary completion date: Oct 2023 --> Oct 2025
    Trial primary completion date • Minimal residual disease
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    CD34 (CD34 molecule)
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    BHV-1100 • CIML NK
    over1year
    Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1, N=25, Recruiting, Biohaven Pharmaceuticals, Inc. | Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2023 --> Oct 2023
    Trial completion date • Trial primary completion date • Minimal residual disease
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    CD34 (CD34 molecule)
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    BHV-1100 • CIML NK
    almost2years
    Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1, N=25, Recruiting, Biohaven Pharmaceuticals, Inc. | Phase classification: P1/2 --> P1
    Phase classification • Minimal residual disease
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    CD34 (CD34 molecule)
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    BHV-1100 • CIML NK
    3years
    Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1/2, N=25, Recruiting, Biohaven Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy • Minimal residual disease
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    CD34 (CD34 molecule)
    |
    BHV-1100
    over3years
    Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1/2, N=25, Not yet recruiting, Biohaven Pharmaceuticals, Inc. | Trial completion date: Feb 2023 --> Jun 2026 | Trial primary completion date: May 2022 --> Jun 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • Minimal residual disease
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    CD34 (CD34 molecule)
    |
    BHV-1100
    almost4years
    Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1/2, N=25, Not yet recruiting, Kleo Pharmaceuticals | Trial completion date: Feb 2022 --> Feb 2023 | Initiation date: Nov 2020 --> Mar 2021 | Trial primary completion date: Dec 2021 --> Mar 2022
    Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Minimal residual disease
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    CD34 (CD34 molecule)
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    BHV-1100
    over4years
    [VIRTUAL] A first-in-class ex vivo combination between cytokine-induced memory like (CIML) NK cells and a CD38 targeting antibody recruiting molecule (ARM) as a novel approach to target NK cells without cellular engineering for the treatment of multiple myeloma. (ASCO 2020)
    The activity of CIML NK cells towards CD38 expressing MM target cells is improved by the addition of KP1237 avoiding the need for cellular engineering with chimeric antigen receptors. This led to the development of the combination drug product consisting of patient autologous CIML NK cells, KP1237 and IVIG. Clinical development is under way for (MRD+) MM patients eligible for ASCT.
    Preclinical • IO biomarker
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    CD38 (CD38 Molecule) • NCAM1 (Neural cell adhesion molecule 1) • IL18 (Interleukin 18) • NKG2D (killer cell lectin like receptor K1)
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    BHV-1100