First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (NCT03625037)
A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Mayo Clinic — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (85 Sites)
Showing the first 25 of 85 sites.
- Arizona Mayo Clinic — Phoenix, Arizona
- University of California at San Francisco — San Francisco, California
- Colorado Blood Cancer Institute — Denver, Colorado
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
- University of Iowa Hospital and Clinics — Iowa City, Iowa
- Ochsner Medical Center — New Orleans, Louisiana
- University of Michigan — Ann Arbor, Michigan
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
- University of Nebraska Medical Center — Omaha, Nebraska
- Hackensack Meridian Health — Hackensack, New Jersey
- The Cleveland Clinic Foundation — Cleveland, Ohio
- OHSU Knight Cancer Institute — Portland, Oregon
- Hillman Cancer Center — Pittsburgh, Pennsylvania
- Rhode Island Hospital — Providence, Rhode Island
- Medical University of South Carolina — Charleston, South Carolina
- UT Southwestern — Dallas, Texas
- MD Anderson Cancer Center — Houston, Texas
- Monash Health — Clayton,
- Concord Hospital — Concord,
- St. Vincent Hospital — Fitzroy,
- Royal Brisbane and Women's Hospital — Herston,
- Royal Hobart Hospital RHH — Hobart,
- St. George Hospital — Kogarah,
- Cabrini Hospital — Malvern,
- Sir Charles Gairdner Hospital — Nedlands,
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.