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    DRUG:

    vonsetamig (REGN5459)

    i
    Other names: REGN5459, REGN-5459, REGN 5459
    Associations

    News

    Trials
    Company:
    Regeneron, Sanofi
    Drug class:
    CD3 agonist, BCMA inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis (clinicaltrials.gov)
    P1, N=126, Not yet recruiting, Regeneron Pharmaceuticals | N=72 --> 126
    Enrollment change
    |
    Ordspono (odronextamab) • vonsetamig (REGN5459)
    6ms
    First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov)
    P1/2, N=43, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Nov 2025 --> May 2025 | Trial primary completion date: Nov 2025 --> May 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    vonsetamig (REGN5459)
    7ms
    Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis (clinicaltrials.gov)
    P1, N=72, Not yet recruiting, Regeneron Pharmaceuticals
    New P1 trial
    |
    vonsetamig (REGN5459)
    9ms
    An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant (clinicaltrials.gov)
    P=N/A, N=20, Recruiting, Regeneron Pharmaceuticals | N=12 --> 20 | Trial completion date: May 2026 --> Dec 2027
    Enrollment change • Trial completion date
    |
    vonsetamig (REGN5459)
    10ms
    A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA) (clinicaltrials.gov)
    P1/2, N=56, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Oct 2025 --> Jan 2027 | Trial primary completion date: Oct 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    vonsetamig (REGN5459)
    over2years
    First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov)
    P1/2, N=43, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Nov 2023 --> Nov 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    vonsetamig (REGN5459)
    over2years
    BCMAxCD3 Bispecific Yields Robust Responses in Myeloma. (PubMed, Cancer Discov)
    In emerging data from a phase I/II trial, patients with relapsed/refractory multiple myeloma responded well to REGN5459, an investigational BCMA-targeting bispecific T-cell engager. However, despite the drug's low affinity for CD3 on T cells, this design did not mitigate the risk of cytokine release syndrome, a common toxicity.
    Journal
    |
    vonsetamig (REGN5459)