Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)
NCT06796998 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-10-28
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).
Conditions
- Marginal Zone Lymphoma
- Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Splenic Marginal Zone Lymphoma
- Nodal Marginal Zone Lymphoma
Interventions
- BIOLOGICAL
-
Epcoritamab
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
Sponsors & Collaborators
-
Genmab
collaborator INDUSTRY - collaborator INDUSTRY
-
Izidore Lossos, MD
lead OTHER
Principal Investigators
-
Izidore Lossos, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-13
- Primary Completion
- 2028-10-15
- Completion
- 2031-04-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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