Reid Merryman, MD
The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL) or marginal zone lymphoma (MZL). * The names of the study drugs involved in this research study are: * Epcoritamab (a type of antibody) * Zanubrutinib (a type of Bruton tyrosine kinase inhibitor) * Rituximab (a type of monoclonal antibody)
This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of epcoritamab, zanubrutinib, and rituximab (EZR) for participants with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The trial will commence with a six participant lead-in cohort for each disease type. The U.S. Food and Drug Administration (FDA) has approved epcoritamab for people who have received at least 2 prior treatments for follicular lymphoma. Epcoritamab is not approved for patients with marginal zone lymphoma. The U.S. FDA has approved zanubrutinib (in combinati…
Inclusion Criteria: * Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) or CD20+ MZL (any subtype) (at time of trial entry) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current histologic transformation are excluded. * Receipt of at least one prior line of therapy for FL or MZL (with prior treatment including a CD20 monoclonal antibody). * Measurable disease, defined as ≥1 measurable nodal lesion (long axis \>1.5 cm or short axis \>1.0 cm), or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm), or spleen \>13 cm on PET,…
Bruton tyrosine kinase inhibitor, 80 mg immediate-release capsule, taken orally per protocol.
Chimeric anti-CD20 monoclonal antibody, 10 or 50 mL single-use vials, via intravenous infusion per institutional standard.
Bispecific antibody, 5 or 60 mg/mL vials, via subcutaneous (under the skin) injection per protocol.