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NCT Number: NCT05685173

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

This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug[s]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs).

The study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab.

The goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works.

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)

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Key information

Conditions

B-cell Non-Hodgkins Lymphoma (B-NHL) Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Bordeaux, Talence, New Aquitaine, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.
  • Measurable disease on cross sectional imaging as defined in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow, renal and hepatic function as defined in the protocol
  • 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
  • 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:

  • Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab
  • Diagnosis of Mantle Cell Lymphoma (MCL)
  • Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
  • 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
  • Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab
  • Co-morbid conditions, as described in the protocol
  • Infections, as described in the protocol
  • Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase

NOTE: Other protocol defined inclusion / exclusion criteria apply

Treatment and study plan

Odronextamab

Drug

Administered per the protocol

Other names: REGN1979, Ordspono™

REGN5837

Drug

Administered per the protocol

Primary outcomes

  1. Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab

    Time frame: From Cycle 2, Day 1 to Cycle 2, Day 21 (each induction cycle is 21 days)

    A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications).

  2. Incidence of Treatment-Emergent Adverse Events (TEAEs) of REGN5837 in combination with odronextamab

    Time frame: Up to approximatively 5 years

    Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

  3. Severity of TEAEs of REGN5837 in combination with odronextamab

    Time frame: Up to approximatively 5 years

    Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

  4. Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab

    Time frame: Up to approximatively 5 years

    An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

  5. Severity of AESIs of REGN5837 in combination with odronextamab

    Time frame: Up to approximatively 5 years

    An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

Secondary outcomes

  1. Concentrations of REGN5837 in the serum

    Time frame: Up to 90 days post last study drug administration

  2. Concentrations of odronextamab in the serum

    Time frame: Up to 90 days post last study drug administration

  3. Occurrence of Anti-Drug Antibodies (ADAs) to REGN5837

    Time frame: Up to 90 days post last study drug administration

  4. Occurrence of ADAs to odronextamab

    Time frame: Up to 90 days post last study drug administration

  5. Magnitude of ADAs to REGN5837

    Time frame: Up to 90 days post last study drug administration

  6. Magnitude of ADAs to odronextamab

    Time frame: Up to 90 days post last study drug administration

  7. Objective Response Rate (ORR) according to the Lugano Classification of response

    Time frame: Up to approximatively 5 years

    The ORR is defined as the proportion of patients who achieve a best overall response CR or PR during or following study treatment according to the Lugano Classification based on local investigator review.

  8. Complete Response (CR) according to the Lugano Classification of response

    Time frame: Up to approximatively 5 years

    The CR rate is defined as the proportion of patients who achieve a best overall response CR during or following study treatment according to the Lugano Classification based on local investigator review.

  9. Overall Survival (OS)

    Time frame: Up to approximatively 5 years

    OS is measured from the start of study treatment until death due to any cause.

  10. Progression Free Survival (PFS) according to the Lugano Classification of response

    Time frame: Up to approximatively 5 years

    PFS is defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.

  11. Duration of Response (DoR) according to the Lugano Classification of response

    Time frame: Up to approximatively 5 years

    DOR is defined for responders (patients with a best overall response of CR or PR). It is the time from the date of the first documented CR or PR until the date of the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: ATHENA-1

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Jan 13, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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