A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas

ID#: NCT05685173

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: April 12, 2023

End Date: May 16, 2029

Contact Information:
Clinical Trials Administrator
Summary: The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2 for the combination. The study is focused on patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs). The study is looking at several other research questions, including: - What side effects may happen from taking the study drugs - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects) - To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)
Eligibility: Key

Inclusion Criteria:

1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent.

2. Measurable disease on cross sectional imaging as defined in the protocol

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

4. Adequate bone marrow, renal and hepatic function as defined in the protocol

5. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant. Key

Exclusion Criteria:

1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab

2. Diagnosis of mantle cell lymphoma (MCL)

3. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS lymphoma

4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter

5. Standard radiotherapy within 14 days of first administration of study drug.

6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab

7. Co-morbid conditions, as described in the protocol

8. Infections, as described in the protocol

9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase NOTE: Other protocol defined inclusion / exclusion criteria apply