Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06796998

Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

Led by Izidore Lossos, MD · Updated on 2025-10-28

25

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

Sponsors

I

Izidore Lossos, MD

Lead Sponsor

G

Genmab

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).

CONDITIONS

Official Title

Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 years or older who can sign informed consent
  • Ability to follow the trial protocol
  • Histologically confirmed Marginal Zone Lymphoma (extranodal, nodal, or splenic subtypes) with stage I-IV disease
  • No prior systemic treatment for MZL; previous localized therapy or antibiotics for H. pylori-positive gastric EMZL allowed under conditions
  • Radiographically measurable disease or specific lesion criteria for skin, gastric, conjunctival, or splenic MZL
  • Willingness to provide tissue or bone marrow biopsy if needed
  • Meets at least one treatment initiation criterion such as threatened organ function, nodal involvement, tumor size, B symptoms, splenomegaly, leukopenia, or other disease-related symptoms
  • Life expectancy greater than 3 months
  • ECOG performance status 0 to 2
  • Adequate blood counts and organ function within 6 weeks prior to therapy
  • Willing to avoid pregnancy during and for 90 days after treatment
Not Eligible

You will not qualify if you...

  • Evidence of transformation to diffuse large B-cell lymphoma (DLBCL)
  • History of central nervous system lymphoma or leptomeningeal disease (except dural MZL)
  • Prior or concurrent anticancer therapies
  • Recent use of systemic immunosuppressive drugs above specified doses
  • Previous stem cell transplant or CAR T-cell therapy
  • Active graft versus host disease
  • Unrecovered surgical complications
  • Other recent malignancies except certain noninvasive cancers
  • Significant uncontrolled medical conditions
  • Active serious infections or recent major infections
  • Recent live vaccine exposure or planned during study
  • Known HIV infection
  • History of solid organ transplantation
  • Severe allergic reactions to monoclonal antibodies
  • Known allergies to study drug components
  • Serious cardiovascular or pulmonary disease
  • Known chronic active Epstein-Barr virus infection
  • History of certain immune or neurological disorders
  • Active hepatitis B or C infection unless controlled
  • History of autoimmune diseases except well-controlled cases under specific conditions
  • Active COVID-19 infection or symptoms without negative testing
  • Impaired decision-making capacity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

I

Izidore Lossos, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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