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

Phase 1

• Conditions: Relapsed/refractory B-cell non-Hodgkin lymphoma (NHL); MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002139-41-DE
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 512

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 (Swerdlow, 2017).
• Disease-specific cohorts:
• FL grade 1-3a cohort: Patients with FL grade 1-3a 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: Not currently enrolling patients with mantle cell lymphoma (MCL) as of Global Amendment 3
• MZL cohort: Patients with MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. As of Global Protocol Amendment 6 enrollment has resumed for patients with MZL.
• 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. Burkitt lymphoma and Burkitt-like lymphoma with 11q aberration are excluded as of global amendment 4
• Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment and deemed not appropriate for any other approved therapy with established benefit for that indication.
• Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI))
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate bone marrow, hepatic, and renal function as defined in the protocol
Note: Other protocol defined Inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 205
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 307

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).
• Treatment with any systemic anti-lymphoma therapy within 5 halflives 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 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; or other uncontrolled infection as defined in the protocol
• Known hypersensitivity to both allopurinol and rasburicase
• Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
Note: Other protocol defined Exclusion criteria apply

Study & Design

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