Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

The trial is an open-label, multi-center safety trial of epcoritamab GEN3013 (DuoBody®-CD3xCD20). The trial consists of two parts: a dose escalation part phase 1, first-in-human (FIH) and an expansion part phase 2a.

Official Title

A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Details

The purpose of the escalation part of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose (RP2D) as well as to establish the safety profile of epcoritamab GEN3013 (DuoBody®-CD3xCD20) in patients with relapsed, progressive or refractory B-Cell Lymphoma. In the expansion part additional patients will be treated with epcoritamab with the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

Keywords

Diffuse Large B-cell Lymphoma High-grade B-cell Lymphoma Primary Mediastinal Large B-cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Lymphoma Lymphoma, B-Cell Lymphoma, Mantle-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large B-Cell, Diffuse Epcoritamab Epcoritamab (GEN3013, DuoBody®-CD3xCD20)

Eligibility

For people ages 18 years and up

Main Inclusion Criteria Escalation Part

  • Documented CD20+ mature B-cell neoplasm
  • Diffuse large B-cell lymphoma - de novo or transformed
  • High-grade B-cell lymphoma
  • Primary mediastinal large B-cell lymphoma
  • Follicular lymphoma
  • Mantle cell lymphoma
  • Small lymphocytic lymphoma
  • Marginal zone lymphoma (nodal, extranodal or mucosa associated)
  • Relapsed, progressive and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
  • ECOG performance status 0,1 or 2
  • Patients must have measurable disease by CT, MRI or PET-CT scan
  • Acceptable renal function
  • Acceptable liver function

Main Inclusion Criteria Expansion Part

  • Documented CD20 positive mature B cell neoplasm or CD20+ MCL
  • Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple hit)
  • Primary mediastinal large B cell lymphoma
  • Follicular lymphoma grade 3B
  • Histologic confirmed follicular lymphoma
  • Marginal zone lymphomas
  • Small lymphocytic lymphoma
  • Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)
  • At least 2 therapies including an anti CD20 monoclonal antibody containing chemotherapy combination regimen
  • Either failed prior autologous hematopoietic stem cell transplantation or ineligible for autologous stem cell transplantation due to age or comorbidities
  • At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes

Locations

  • University of California at San Francisco accepting new patients
    San Francisco California 94117 United States
  • Arizona Mayo Clinic accepting new patients
    Phoenix Arizona 85054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genmab
ID
NCT03625037
Phase
Phase 1/2
Study Type
Interventional
Last Updated