GCT3013-05


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

Trial summary:

Phase 3 study of epcoritamab (GEN3013; DuoBody®-CD3xCD20) versus prespecified investigator’s choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma

Receptor status / problem studied:

Diffuse large B-cell lymphoma

Inclusion criteria

  • 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
  • One of the confirmed histologies below with CD20-positivity:
    • a. DLBCL, NOS, including de novo or histologically transformed from FL
    • b. “”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
    • c. FL Grade 3B
  • ECOG PS score of 0-2
  • Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
  • Patients must have detectable disease by PET scan and measurable by CT scan or MRI
  • Acceptable renal and liver function
  • Life expectancy >2 months on SOC treatment

Exclusion criteria

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

View more trial information

Open for recruitment

Trial Title

GCT3013-05

Diagnosis

Lymphoma – B-cell Non Hodgkin’s

Type of trial

Pharmaceutical

Type of treatement

Haematology

Phase

III

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