A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in patients with B-cell non-Hodgkin Lymphoma that have been previously treated

Phase 1

Recruiting

• Conditions: B-cell non-Hodgkin lymphoma (NHL); MedDRA version: 21.0Level: PTClassification code: 10012818Term: Diffuse large B-cell lymphoma Class: 100000004864; MedDRA version: 23.1Level: LLTClassification code: 10084346Term: B-cell non-Hodgkin´s lymphoma Class: 100000004848; MedDRA version: 21.1Level: PTClassification code: 10061170Term: Follicle centre lymphoma follicular grade I II III Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10061275Term: Mantle cell lymphoma Class: 100000004864; MedDRA version: 23.0Level: PTClassification code: 10063908Term: Non-Hodgkin's lymphoma unspecified histology aggressive Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10003899Term: B-cell lymphoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10076596Term: Marginal zone lymphoma Class: 100000004864; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2024-511747-25-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

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, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, Other protocol-defined inclusion criteria apply, Adequate bone marrow, hepatic, and renal function as defined in the protocol, Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol, 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, MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice, MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy., 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., Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment, Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)

Exclusion Criteria

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)., Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy, Other protocol-defined exclusion criteria apply, 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., History of allogeneic stem cell transplantation, Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy, 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, History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded, 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., Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections, Known hypersensitivity to both allopurinol and rasburicase

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified