REGN5837 and Odronextamab for Aggressive B-cell Non-Hodgkin Lymphomas
This study is testing a combination of two experimental drugs, REGN5837 and odronextamab, for adults with aggressive B-cell Non-Hodgkin Lymphoma (B-NHL). You might be able to join if your lymphoma has progressed after at least two previous treatments, including an anti-CD20 antibody and an alkylating agent, and you have measurable disease. The main goal is to find a safe dose of REGN5837 when given with odronextamab, and then to see how well this combination works. Researchers will also track any side effects and how your body handles the drugs. The study is looking to enroll about 107 participants.
- Study design
- This is an interventional study with two parts: first, finding a safe dose, and then, testing how well that dose works. It plans to enroll about 107 adult participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for potential side effects for up to approximately 5 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
At a glance
Conditions
NCT05685173
Where you'd take part
This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Amsterdam University Medical Centre, location AMC
Amsterdam, Netherlandsno site contact published
Recruiting
CHU de Bordeaux
Talence, New Aquitaine, Franceno site contact published
Recruiting
City of Hope
Duarte, Californiano site contact published
Recruiting
Erasmus Medical Center Rotterdam
Rotterdam, South Holland, Netherlandsno site contact published
Recruiting
Gustave Roussy
Villejuif, Île-de-France Region, Franceno site contact published
Recruiting
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusettsno site contact published
Recruiting
Hopital Saint Louis
Paris, Franceno site contact published
Recruiting
Hospital Vall d'Hebron
Barcelona, Spainno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamabFrom 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 odronextamabUp 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 odronextamabUp 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 odronextamabUp 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 odronextamabUp 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.