RecruitingPhase 2NCT06796998

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

Phase 2 Trial of Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)


Sponsor

Izidore Lossos, MD

Enrollment

25 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called epcoritamab — a bispecific antibody that helps the immune system attack lymphoma cells — as a first-time treatment for patients newly diagnosed with a type of slow-growing blood cancer called Marginal Zone Lymphoma (MZL). Epcoritamab is given as an injection under the skin. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Marginal Zone Lymphoma (MZL) — including extranodal, nodal, or splenic subtypes — at any stage - You have not previously received treatment for MZL (some exceptions apply for localized therapy or antibiotic treatment of stomach MZL) - You are willing and able to follow the study requirements **You may NOT be eligible if...** - You have received prior systemic treatment for MZL - You have significant organ problems or conditions that make the study unsafe - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEpcoritamab

Epcoritamab will be administered via subcutaneous (SC) injection using a step-up dosing schedule as follows: * Cycle 1, Day 1: 0.16 mg * Cycle 1, Day 8: 0.8 mg * Cycle 1, Day 15: 3 mg * Cycle 1, Day 22: 48 mg * Cycles 2 to 3, Days 1, 8, 15 and 22: 48 mg * Cycles 4 to 9, Days 1 and 15: 48 mg * Cycles 10 to 12; Day 1: 48 mg


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06796998


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