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NotablePrimary endpoints: details revised at 1 of 4 entriesEligibility criteria expanded, about 43 words · Secondary endpoints: details revised at 5 of 35 entries · Site details revised at 2 of 85 sites · 2 moreShow 5 more changesShow less
Eligibility criteria expanded, about 43 words
Secondary endpoints: details revised at 5 of 35 entries
Site details revised at 2 of 85 sites
Publications: 8 to 9
Study description expanded, about 3 words
Minor13 versionsRe-verified since Aug 4, 2025, no change to tracked fieldsv45-v57
MinorPublications: details revised at 2 of 8 entriesv44
NotablePrimary completion date: Apr 2026 to Jan 2029Publications: details revised at 2 of 8 entriesv43Show 1 more changeShow less
Publications: details revised at 2 of 8 entries
MinorRe-verified, no change to tracked fieldsv42
Show 33 earlier versionsHide 33 earlier versions
MinorEligibility criteria expanded, about 26 wordsSecondary endpoints: 37 to 35v41Show 1 more changeShow less
Minor8 versionsRe-verified since Jul 1, 2024, no change to tracked fieldsv31-v38
MinorPublications: details revised at 1 of 8 entriesv30
Minor3 versionsRe-verified since Apr 4, 2024, no change to tracked fieldsv27-v29
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 826 to confirmed 666 · Study sites: 93 to 85 · Primary completion date: Jan 2025 to Mar 2025 · 1 morev26Show 4 more changesShow less
Enrollment target: estimated 826 to confirmed 666
Study sites: 93 to 85
Primary completion date: Jan 2025 to Mar 2025
Completion date: Apr 2029 to Jan 2029
MinorRe-verified, no change to tracked fieldsv25
NotablePrimary endpoints: 5 to 4Enrollment target: 786 to 826 · Eligibility criteria expanded, about 13 words · Secondary endpoints: 27 to 37 · 1 morev24Show 4 more changesShow less
MinorEnrollment target: 700 to 786Site details revised at 13 of 93 sitesv21Show 1 more changeShow less
Site details revised at 13 of 93 sites
MinorRe-verified, no change to tracked fieldsv20
MinorStudy Status, Study Description, Arms and Interventions, Referencesv19
NotablePrimary completion date: Oct 30, 2023 to Jan 2025Primary endpoints: 4 to 5 · Completion date: Jul 1, 2025 to Apr 2029 · Eligibility criteria shortened, about 34 words · 3 morev18Show 6 more changesShow less
NotablePrimary endpoints: 3 to 4Enrollment target: 486 to 700 · Eligibility criteria expanded, about 272 words · Secondary endpoints: 22 to 27 · 2 morev15Show 5 more changesShow less
NotablePrimary completion date: Jan 30, 2022 to Oct 30, 2023Primary endpoints: 4 to 3 · Completion date: Dec 30, 2025 to Jul 1, 2025 · Start date: Jun 26, 2018 to Jul 3, 2018 · 4 morev14Show 7 more changesShow less
NotableEnrollment target: 110 to 386Study sites: 10 to 29 · Interventions: GEN3013 (DuoBody®-CD3xCD20) (Biological) to Epcoritamab (Biological)v10Show 2 more changesShow less
Study sites: 10 to 29
Interventions: GEN3013 (DuoBody®-CD3xCD20) (Biological) to Epcoritamab (Biological)
MinorSite details revised at 1 of 10 sitesv9
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.