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First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Condition: DLBCL · High-grade B-cell Lymphoma (HGBCL) · Primary Mediastinal Large B-cell Lymphoma (PMBCL) · Sponsor: Genmab
About this study
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, participa…
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (85)
| Arizona Mayo Clinic | Phoenix, Arizona, United States | — |
| University of California at San Francisco | San Francisco, California, United States | — |
| Colorado Blood Cancer Institute | Denver, Colorado, United States | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida, United States | — |
| University of Iowa Hospital and Clinics | Iowa City, Iowa, United States | — |
| Ochsner Medical Center | New Orleans, Louisiana, United States | — |
| University of Michigan | Ann Arbor, Michigan, United States | — |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, United States | — |
| University of Nebraska Medical Center | Omaha, Nebraska, United States | — |
| Hackensack Meridian Health | Hackensack, New Jersey, United States | — |
| The Cleveland Clinic Foundation | Cleveland, Ohio, United States | — |
| OHSU Knight Cancer Institute | Portland, Oregon, United States | — |
+ 73 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03625037