Relapsed or refractory B-cell non-Hodgkin Lymphoma Relapsed B-NHL, Refractory B-NHL, NHL, FL, DLBCL, MZL, MCL, bispecific antibody, CD20
Conditions
Interventions
Drug: Odronextamab
Administered by intravenous (IV) infusion
Other Name: REGN1979
Sponsors
Srikanth R. Ambati
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017). 2. Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol 3. DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol 4. MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice 5. MZL cohort: New enrollment is paused until further notice 6. Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma. 7. Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment 8. Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)) 9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 10. Adequate bone marrow, hepatic, and renal function as defined in the protocol
Exclusion criteria
Exclusion criteria: 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI). 2. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter. 3. History of allogeneic stem cell transplantation 4. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug 5. History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded 6. Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent. 7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection as defined in the protocol 8. Known hypersensitivity to both allopurinol and rasburicase 9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy Note: Other protocol-defined Inclusion/Exclusion criteria apply for NCT03888105
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.ORR (FL grade 1-3a/MZL) [ Time Frame: From first patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study] According to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review. 2.ORR (DLBCL/MCL/Other B-NHL) [ Time Frame: From first patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study] According to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review. | — |
Secondary
| Measure | Time frame |
|---|---|
| - ORR (FL/MZL) [ Time Frame: First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study. ] According to the Lugano Classification, as assessed by local investigator evaluation - ORR (DLBCL/MCL/Other B-NHL) [ Time Frame: First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study. ] According to the Lugano Classification, as assessed by local investigator evaluation - CR rate (FL grade 1-3a/MZL) [ Time Frame: First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study. ] According to the Lugano Classification and as assessed by local investigator evaluation and independent central review - CR rate (DLBCL/MCL/Other B-NHL) [ Time Frame: First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study. ] According to the Lugano Classification and as assessed by local investigator evaluation and independent central review - PFS [ Time Frame: First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose ] According to the Lugano Classification and as assessed by independent central review and local investigator evaluation - OS [ Time Frame: First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose] - DOR [ Time Frame: First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose] According to the Lugano Classification and as assessed by independent central review and local investigator evaluation - DCR (FL grade 1-3a/MZL) [ Time Frame: First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.] According to the Lugano Classif | — |
Countries
Australia, Canada, China, France, Germany, Italy, Japan, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactRosario Chikako
Parexel International
Outcome results
None listed