^
    2ms
    GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=252, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
    7ms
    GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=252, Recruiting, Genmab | Trial primary completion date: Mar 2025 --> Oct 2024
    Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
    7ms
    GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=252, Recruiting, Genmab | Trial primary completion date: Oct 2024 --> Mar 2025
    Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
    11ms
    GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=252, Recruiting, Genmab | Trial completion date: Feb 2029 --> Dec 2026
    Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
    over1year
    Preclinical anti-tumour activity of HexaBody-CD38, a next-generation CD38 antibody with superior complement-dependent cytotoxic activity. (PubMed, EBioMedicine)
    Based on these preclinical studies, a clinical trial was initiated to assess the clinical safety of HexaBody-CD38 in patients with MM.
    Preclinical • Journal • IO biomarker
    |
    CD38 expression
    |
    Darzalex (daratumumab) • GEN3014
    over1year
    PHARMACODYNAMIC ACTIVITY OF GEN3014 (HEXABODY-CD38) IN PATIENTS WITH MULTIPLE MYELOMA SUPPORTS ENHANCED COMPLEMENT DEPENDENT CYTOTOXICITY OF GEN3014 COMPARED TO DARATUMUMAB (EHA 2023)
    GEN3014 showed potent CDC activity in vitro, with higher maximal kill compared to daratumumab, also under suboptimal complement conditions. GEN3014 induced a stronger decline of complement levels in patients compared to historical data of daratumumab, supporting its potential to induce enhanced CDC in patients. These findings support the ongoing phase 1/2 trial in patients with RRMM (NCT04824794) evaluating the safety and efficacy of GEN3014, which includes a head-to-head comparison with daratumumab.
    Clinical • PK/PD data • IO biomarker
    |
    Darzalex (daratumumab) • GEN3014
    over1year
    GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=252, Recruiting, Genmab | Trial completion date: Jan 2024 --> Feb 2029 | Trial primary completion date: Apr 2023 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
    2years
    GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=272, Recruiting, Genmab | N=152 --> 272
    Enrollment change
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
    2years
    Preliminary Dose-Escalation Results from a Phase 1/2 Study of GEN3014 (HexaBody®-CD38) in Patients (pts) with Relapsed or Refractory Multiple Myeloma (RRMM) (ASH 2022)
    Most pts (67%) had prior exposure to a daratumumab- or isatuximab-containing regimen, with 8 pts naive to anti-CD38 mAb. Dose-escalation results show GEN3014 had a tolerable safety profile and clinical activity in pts with RRMM, including pts with prior anti-CD38 mAb. The PK profile is characterized by target-mediated drug disposition at lower doses and signs of saturation at doses >8 mg/kg. Biomarker analyses confirm biological activity in pts with RRMM at all evaluated doses.
    Clinical • P1/2 data • IO biomarker
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc) • GEN3014
    4years
    [VIRTUAL] Preclinical Anti-Tumor Activity of Hexabody-CD38 in Patient-Derived B Cell Lymphoma and Acute Myeloid Leukemia Xenograft Models (ASH 2020)
    In this study, we show that in a panel of 23 MM, AML and B-NHL cell lines HexaBody-CD38 induced CDC, with EC50 values on average 7-fold lower than those of the CD38-targeting mAb daratumumab, which is part of the standard of care for MM. This indicates that besides highly potent CDC, FcɣR-mediated effector mechanisms contribute to the preclinical activity of HexaBody-CD38 in hematological tumor models. These preclinical data support clinical investigation of HexaBody-CD38 in CD38 positive hematologic malignancies, including MM, AML, and B cell lymphomas.
    IO biomarker
    |
    CD38 (CD38 Molecule)
    |
    CD38 expression • CD38 positive
    |
    Darzalex (daratumumab) • GEN3014