RECRUITING

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

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Conditions

B-cell Non-Hodgkins Lymphoma (B-NHL)Aggressive B-Cell Non-Hodgkin LymphomasRelapsed or Refractory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab (called "study drugs"). 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. 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 the 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)

Official Title

A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)

Quick Facts

Study Start:2023-04-12
Study Completion:2029-05-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05685173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Measurable disease on cross sectional imaging as defined in the protocol
  3. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  4. 4. Adequate bone marrow, renal and hepatic function as defined in the protocol
  5. 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. 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.
  1. 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. 2. Diagnosis of mantle cell lymphoma (MCL)
  3. 3. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
  4. 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. 5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
  6. 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. 7. Co-morbid conditions, as described in the protocol
  8. 8. Infections, as described in the protocol
  9. 9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Norton Cancer Institute
Louisville, Kentucky, 40241
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215-5400
United States
Robert Wood Johnson University Hospital New Brunswick
New Brunswick, New Jersey, 08903
United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of Texas (UT) - Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12
Study Completion Date2029-05-16

Study Record Updates

Study Start Date2023-04-12
Study Completion Date2029-05-16

Terms related to this study

Keywords Provided by Researchers

  • Aggressive B-Cell Non-Hodgkin Lymphomas
  • Relapsed or Refractory

Additional Relevant MeSH Terms

  • B-cell Non-Hodgkins Lymphoma (B-NHL)