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

Conditions

• B-cell Non-Hodgkins Lymphoma (B-NHL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Odronextamab — DRUG
  Administered per the protocol
• REGN5837 — DRUG
  Administered per the protocol

Study Details

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)

Key Dates

Start date

Apr 20, 2023

Status verified

May 2026

Primary completion

Feb 16, 2029

Completion

Jan 13, 2030

Study Design

Enrollment

107 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose escalation portion
• Experimental: Dose expansion portion

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) ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (9)

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