First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Study Identifier
GCT3013-01
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
2023-504802-12-00
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Recruitment Complete
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Study Details

Medical Condition
  • Blood Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Blood Cancer - Follicular Lymphoma (FL)
  • Blood Cancer - Mantle Cell Lymphoma (MCL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
  • Study Drug
  • Epcoritamab
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):

    • The dose schedule for epcoritamab
    • The side effects seen with epcoritamab
    • What the body does with epcoritamab once it is administered
    • What epcoritamab does to the body once it is administered
    • How well epcoritamab works against relapsed and/or refractory B-cell lymphoma

    The trial consists of 3 parts:

    • a dose-escalation part (Phase 1, first-in-human \[FIH\])
    • an expansion part (Phase 2a)
    • a dose-optimization part (OPT) (Phase 2a)

    The trial time for each participant depends on which trial part the participant enters:

    • For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
    • For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).

    Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.

    All participants will receive active drug, and no participants will be given placebo.

    Study Locations

    Location
    Status
    Location
    Arizona Mayo Clinic
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    University of California at San Francisco
    San Francisco, California, United States, 94117
    Status
    Not applicable
    Location
    Colorado Blood Cancer Institute
    Denver, Colorado, United States, 80218
    Status
    Not applicable
    Location
    H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida, United States, 33612
    Status
    Not applicable
    Location
    University of Iowa Hospital and Clinics
    Iowa City, Iowa, United States, 52242
    Status
    Not applicable
    Location
    Ochsner Medical Center
    New Orleans, Louisiana, United States, 70121
    Status
    Not applicable
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