B-cell Non-Hodgkins Lymphoma (B-NHL)Phase 1ATHENA-1NCT05685173
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
A Phase 1 study testing Odronextamab and REGN5837 in people with B-cell Non-Hodgkins Lymphoma (B-NHL), run by Regeneron Pharmaceuticals at 20 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkins Lymphoma (B-NHL)
- What is being tested?
- Odronextamab and REGN5837
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 20 Apr 2023to 13 Jan 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
United States9 sites, 9 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
UT Southwestern
Dallas, Texas, 75390
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40207
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
- Recruiting
NYU Langone Health Perlmutter Cancer Center
New York, New York, 10016
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
University of California Los Angeles (UCLA) Medical Center
Santa Monica, California, 90404
United Kingdom4 sites, 4 recruiting
- Recruiting
Western General Hospital
Edinburgh, Scotland, EH4 2XU
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
- Recruiting
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
- Recruiting
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
France3 sites, 3 recruiting
- Recruiting
Hopital Saint Louis
Paris, 75010
- Recruiting
CHU de Bordeaux
Talence, New Aquitaine, 33404
- Recruiting
Gustave Roussy
Villejuif, Île-de-France Region, 94800
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam University Medical Centre, location AMC
Amsterdam, 1100AZ
- Recruiting
Erasmus Medical Center Rotterdam
Rotterdam, South Holland, 3015
Spain2 sites, 2 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
University Hospital and Research Institute
Madrid, 28041
About this study
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)
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.
Read more
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)
- Conditions
- B-cell Non-Hodgkins Lymphoma (B-NHL)
- Being tested
- Odronextamab, REGN5837
- Keywords
- Aggressive B-Cell Non-Hodgkin Lymphomas, Relapsed or Refractory
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdronextamabDrug
Also called REGN1979, Ordspono™
Administered per the protocol
REGN5837Drug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation portion | Experimental | Not described Receives: Drug: Odronextamab; Drug: REGN5837 |
| Dose expansion portion | Experimental | Not described Receives: Drug: Odronextamab; Drug: REGN5837 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab
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).
Measured: From Cycle 2, Day 1 to Cycle 2, Day 21 (each induction cycle is 21 days)
Incidence of Treatment-Emergent Adverse Events (TEAEs) of REGN5837 in combination with odronextamab
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.
Measured: Up to approximatively 5 years
Severity of TEAEs of REGN5837 in combination with odronextamab
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.
Measured: Up to approximatively 5 years
Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab
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.
Measured: Up to approximatively 5 years
Severity of AESIs of REGN5837 in combination with odronextamab
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.
Measured: Up to approximatively 5 years
Secondary outcomes (11)
Concentrations of REGN5837 in the serum
Measured: Up to 90 days post last study drug administration
Concentrations of odronextamab in the serum
Measured: Up to 90 days post last study drug administration
Occurrence of Anti-Drug Antibodies (ADAs) to REGN5837
Measured: Up to 90 days post last study drug administration
Occurrence of ADAs to odronextamab
Measured: Up to 90 days post last study drug administration
Magnitude of ADAs to REGN5837
Measured: Up to 90 days post last study drug administration
Magnitude of ADAs to odronextamab
Measured: Up to 90 days post last study drug administration
Objective Response Rate (ORR) according to the Lugano Classification of response
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.
Measured: Up to approximatively 5 years
Complete Response (CR) according to the Lugano Classification of response
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.
Measured: Up to approximatively 5 years
Overall Survival (OS)
OS is measured from the start of study treatment until death due to any cause.
Measured: Up to approximatively 5 years
Progression Free Survival (PFS) according to the Lugano Classification of response
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.
Measured: Up to approximatively 5 years
Duration of Response (DoR) according to the Lugano Classification of response
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.
Measured: Up to approximatively 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start20 Apr 2023
- Primary completion16 Feb 2029 (estimated)
- Study completion13 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkins Lymphoma (B-NHL)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685173
- Sponsor's protocol ID
- R5837-ONC-2019
- Other IDs
- 2020-005084-32, 2022-502137-26-00
- Acronym
- ATHENA-1
- Status last verified
- May 2026
- First submitted
- 14 Dec 2022
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05685173
- Acronym / sponsor ID
- ATHENA-1 / R5837-ONC-2019
- Conditions
- B-cell Non-Hodgkins Lymphoma (B-NHL)
- Keywords
- Aggressive B-Cell Non-Hodgkin Lymphomas, Relapsed or Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 16 Feb 2029 (estimated)
- Study completion
- 13 Jan 2030 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation portion | Experimental | Drug: Odronextamab, Drug: REGN5837 |
| Dose expansion portion | Experimental | Drug: Odronextamab, Drug: REGN5837 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OdronextamabAlso: REGN1979, Ordspono™Administered per the protocol | Drug | Dose escalation portion, Dose expansion portion |
| REGN5837Administered per the protocol | Drug | Dose escalation portion, Dose expansion portion |
Primary outcome
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).
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.
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.
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.
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.
11 secondary outcomes
Concentrations of REGN5837 in the serum
Time frame: Up to 90 days post last study drug administration
Concentrations of odronextamab in the serum
Time frame: Up to 90 days post last study drug administration
Occurrence of Anti-Drug Antibodies (ADAs) to REGN5837
Time frame: Up to 90 days post last study drug administration
Occurrence of ADAs to odronextamab
Time frame: Up to 90 days post last study drug administration
Magnitude of ADAs to REGN5837
Time frame: Up to 90 days post last study drug administration
Magnitude of ADAs to odronextamab
Time frame: Up to 90 days post last study drug administration
Objective Response Rate (ORR) according to the Lugano Classification of response
Time frame: Up to approximatively 5 years
Complete Response (CR) according to the Lugano Classification of response
Time frame: Up to approximatively 5 years
Overall Survival (OS)
Time frame: Up to approximatively 5 years
Progression Free Survival (PFS) according to the Lugano Classification of response
Time frame: Up to approximatively 5 years
Duration of Response (DoR) according to the Lugano Classification of response
Time frame: Up to approximatively 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Odronextamab and REGN5837 in people with B-cell Non-Hodgkins Lymphoma (B-NHL), run by Regeneron Pharmaceuticals at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, United Kingdom, France, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.