Testing a new drug combination for aggressive B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and tolerability of an experimental drug, REGN5837, in combination with another experimental drug, odronextamab, for adult patients with aggressive B-cell non-Hodgkin lymphomas that have relapsed or are refractory. The study aims to determine the recommended dose for future phases while assessing side effects, drug levels in the blood, and the body's immune response to the drugs. Participants will undergo evaluations to measure the effectiveness of the treatment against their condition.

Why it matters

Who can join: the full rules

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, as described in the protocol.
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. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
6. 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, as described in the protocol
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, as described in the protocol
5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• University of California Los Angeles (UCLA) Medical Center
  Santa Monica, California, United States Recruiting
• Norton Cancer Institute
  Louisville, Kentucky, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Harvard Medical School - Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Rutgers Cancer Institute of New Jersey
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Odronextamab with CAR T‑cell therapy for relapsed or refractory diffuse large B‑cell lymphoma

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• Testing a new drug combination for relapsed or refractory follicular and marginal zone lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.