for people ages 18 years and up (full criteria)
at Irvine, California and other locations
study started
estimated completion



The drug that will be investigated in the study is an antibody, epcoritamab, also known as GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT

Official Title

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)


The trial is an open label, multi-center, global phase 3 randomized trial of epcoritamab, GEN3013. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.


Diffuse Large B-cell Lymphoma, double-hit DLBCL, triple-hit DLBCL, follicular grade 3B, transformed DLBCL, T-cell histiocytes-rich large B cell lymphoma, Lymphoma, B-Cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Epcoritamab, Investigator's Choice Chemotherapy, Epcoritamab (GEN3013; DuoBody®CD3xCD20)


You can join if…

Open to people ages 18 years and up

  1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis
  2. One of the confirmed histologies below with CD20-positivity:
    1. DLBCL, NOS, including de novo or histologically transformed from FL
    2. "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
    3. FL Grade 3B
    4. T-cell/histiocyte-rich large B-cell lymphoma
  3. ECOG PS score of 0-2
  4. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
  5. Patients must have detectable disease by PET scan and measurable by CT scan or MRI
  6. Acceptable renal and liver function
  7. Life expectancy >2 months on SOC treatment

You CAN'T join if...

  1. Primary Central Nervous System (CNS) tumor or known CNS involvement
  2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
  3. Major surgery within 4 weeks prior to randomization
  4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
  5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
  6. ASCT within 100 days of randomization
  7. Treatment with CAR-T therapy within 100 days prior to randomization
  8. Seizure disorder requiring anti-epileptic therapy
  9. Clinically significant cardiac disease


  • UC Irvine in progress, not accepting new patients
    Irvine California 92697 United States
  • LDS Hospital in progress, not accepting new patients
    Salt Lake City Utah 84143 United States


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Phase 3 research study
Study Type
Expecting 552 study participants
Last Updated