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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Odronextamab will be administered by IV infusion
REGN5837 will be administered by IV infusion
City of Hope
Duarte, California, United States
RECRUITINGUniversity of California Los Angeles (UCLA) Medical Center
Santa Monica, California, United States
RECRUITINGNorton Cancer Institute
Louisville, Kentucky, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGHarvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGNYU Langone Health Perlmutter Cancer Center
New York, New York, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGUT Southwestern
Dallas, Texas, United States
RECRUITINGCHU de Bordeaux
Talence, Nouvelle-Aquitaine, France
RECRUITING...and 10 more locations
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).
Time frame: From Cycle 2, Day 15 to Cycle 4, Day 7 (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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximatively 5 years
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
Incidence of anti-drug antibodies (ADAs) to REGN5837 over the study duration
Time frame: Up to 90 days post last study drug administration
Incidence of ADAs to odronextamab over the study duration
Time frame: Up to 90 days post last study drug administration
Titer of ADAs to REGN5837 over the study duration
Time frame: Up to 90 days post last study drug administration
Titer of ADAs to odronextamab over the study duration
Time frame: Up to 90 days post last study drug administration
Overall 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.
Time frame: Up to approximatively 5 years
Complete response (CR) rate 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.
Time frame: 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.
Time frame: Up to approximatively 5 years
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Overall survival (OS)
OS is measured from the start of study treatment until death due to any cause.
Time frame: 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.
Time frame: Up to approximatively 5 years