Phase 2 Trial of Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)
Izidore Lossos, MD
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men and women aged 18 years or older at the time of signing informed consent. 2. Able and willing to sign the informed consent form (ICF). 3. Ability to comply with the trial protocol. 4. Histologically confirmed Marginal Zone Lymphoma (MZL) of Extranodal Marginal Zone Lymphoma (EMZL), Nodal Marginal Zone Lymphoma (NMZL) and Splenic Marginal Zone Lymphoma (SMZL) subtypes presenting with stage I-IV disease. 5. Previously untreated participants. 1. Participants with H. pylori-positive gastric EMZL who received an initial treatment with currently accepted antibiotics m…
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
Location
- University of MiamiMiami, Florida