Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
University of Miami
Summary
The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body.
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. Relapsed/refractory (r/r) large B-cell lymphoma (LBCL) as determined by the local hematopathology laboratory from the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms (Swerdlow et al., 2016): 1. LBCL or DLBCL, not otherwise specified (NOS) 2. High-grade B-cell lymphoma (NOS or double/triple hit \[technically classified in WHO 2016…
Interventions
- DrugEpcoritamab
Epcoritamab will be administered via subcutaneous injection at the following dose levels and schedule over a total of twelve cycles: * Cycle 1 Day 1: Step-up dose of 0.16 mg * Cycle 1 Day 8: Step-up dose of 0.80 mg * Cycle 1 Day 15: First full dose of 48 mg. * Cycles 2 through 4 Days 1, 8 and 15: 48 mg * Cycles 5 through 12 Days 1 and 15: 48 mg
- DrugLoncastuximab Tesirine
Loncastuximab will be administered intravenously (IV) at the following dose level and schedule over a total of four cycles: * Cycles 1 and 2 Day 1: 120 mcg/kg * Cycles 3 and 4 Day 1: 75 mcg/kg * Cycle 4 Day 22: 75 mcg/kg
Location
- University of MiamiMiami, Florida