A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With… (NCT05685173) | Clinical Trial Compass
RecruitingPhase 1
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
United States107 participantsStarted 2023-04-20
Plain-language 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. 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)
Who can participate
Age range18 Years
SexALL
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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.
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
What they're measuring
1
Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab
Timeframe: From Cycle 2, Day 1 to Cycle 2, Day 21 (each induction cycle is 21 days)
2
Incidence of Treatment-Emergent Adverse Events (TEAEs) of REGN5837 in combination with odronextamab
Timeframe: Up to approximatively 5 years
3
Severity of TEAEs of REGN5837 in combination with odronextamab
Timeframe: Up to approximatively 5 years
4
Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab
Timeframe: Up to approximatively 5 years
5
Severity of AESIs of REGN5837 in combination with odronextamab
✕. 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