Summary

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

Description

Summary

The trial is a global, multi-center safety trial of Epcoritamab, an antibody also known as GEN3013 (DuoBody®-CD3xCD20). The trial consists of three parts: a dose-escalation part (Phase 1, first-in-human (FIH)), an expansion part (Phase 2a) and a dose optimization 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 EPCORE™NHL-1

Details

The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase-2 dose (RP2D), as well as to establish the safety profile of epcoritamab in patients with relapsed, progressive or refractory B-Cell Lymphoma. In the expansion part, additional patients will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab. The dose optimization part will evaluate alternative priming and intermediate dose regimens of epcoritamab. All patients will receive Epcoritamab at the already established full dose.

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

Eligibility

You can join if…

Open to people ages 18 years and up

Escalation Part (recruitment completed)

  • 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 and Optimization Parts

  • 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

NOTE: Other protocol defined Inclusion criteria may apply.

You CAN'T join if...

Escalation, Expansion and Optimization Parts

  • Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening
  • Known past or current malignancy other than inclusion diagnosis
  • AST, and/or ALT >3 × upper limit of normal
  • Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Estimated CrCl <45 mL/min
  • Known clinically significant cardiovascular disease
  • Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics)
  • Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration
  • Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue
  • Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation
  • Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in
  • Known human immunodeficiency virus (HIV) infection
  • Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
  • Pregnancy or breast feeding
  • Patient is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the patient
  • Contraindication to all uric acid lowering agents

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 research study
Study Type
Interventional
Participants
Expecting 700 study participants
Last Updated