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A study of the safety and effectiveness of REGN17372 and linvoseltamab in adults with relapsed or refractory multiple myeloma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Multiple Myeloma, a type of blood cancer, specifically those with the Relapsed/Refractory form, meaning the cancer has returned after previous treatment or has stopped responding to therapy. The purpose of the study is to evaluate the safety and early effectiveness of combining two specific medications. The experimental treatments being studied are linvoseltamab and REGN17372, which are both bispecific monoclonal antibodies. These are specialized proteins designed to attach to specific targets on cancer cells and immune cells at the same time to help the body fight the disease.

The research is conducted in two stages. The first stage focuses on finding the correct dosage by gradually increasing the amount of the drugs to see how well they are tolerated. The second stage looks more closely at how well the combination of linvoseltamab and REGN17372 works to reduce the cancer, or how well linvoseltamab works when used by itself. During the study, participants may also receive background medications such as paracetamol for pain, diphenhydramine hydrochloride to manage certain symptoms, or dexamethasone, which is a type of steroid used to reduce inflammation.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Phase 1: dose escalation

    Participation begins with phase 1, which focuses on dose escalation.

    The goal of this stage is to determine the safety and how well the body tolerates different amounts of the study medications.

    The study drugs administered through an intravenous infusion (medicine delivered directly into a vein) are regn17372 and linvoseltamab.

    During this phase, the amount of medication provided may change to find the recommended phase 2 dose, which is the most effective and safest amount for future use.

  2. Step 2

    Phase 2: dose expansion

    The next stage is phase 2, known as dose expansion.

    This stage evaluates how well the recommended phase 2 dose of the combination therapy (using both regn17372 and linvoseltamab) and linvoseltamab monotherapy (using only linvoseltamab) works against the cancer.

    The focus is on observing anti-tumor activity, which refers to how much the medication reduces the cancer cells.

Who can join the trial?

8 criteria

  • You must have relapsed/refractory multiple myeloma, which means your cancer has returned after treatment or has stopped responding to the medicines you were given.
  • You must have already tried at least three different types of treatment for your condition and found that they no longer work or are no longer an option for you.
  • You must have an ECOG performance status score of 1 or less, which is a way doctors measure how well you can perform daily activities; a score of 0 or 1 means you are still able to walk and do most light work or activities.
  • Your cancer must be measurable, meaning it can be clearly seen and tracked using standard medical tests so doctors can see if the treatment is working.
  • You must have adequate hematologic function, meaning your blood counts (such as red blood cells, white blood cells, and platelets) are at healthy levels.
  • You must have adequate cardiac function, meaning your heart is pumping blood effectively and is strong enough for the study.
  • You must have adequate hepatic function, meaning your liver is working correctly to process substances in your body.
  • You must have adequate renal function, meaning your kidneys are working well to filter waste from your blood.

Who cannot join the trial?

12 criteria

  • People with non-secretory multiple myeloma, which is a type of blood cancer where the cancer cells do not produce certain proteins.
  • People with active plasma cell leukemia, a fast-moving form of blood cancer.
  • People with known amyloidosis, a condition where abnormal proteins build up in organs.
  • People with Waldenström macroglobulinemia, a rare type of blood cancer that affects white blood cells.
  • People with POEMS syndrome, a rare multi-system disease that affects many parts of the body.
  • People with cancer that has spread to the brain or the central nervous system (the part of the body that includes the brain and spinal cord).
  • People with a history of PML, a rare and serious infection of the brain.
  • People with neurocognitive conditions, which are issues affecting thinking, memory, or reasoning.
  • People with central nervous system movement disorders, which are problems that affect how the brain controls body movements.
  • People who have had a seizure within the 12 months before starting the study process.
  • People who have previously received GPRC5D-directed immunotherapies, which are treatments designed to help the immune system fight cancer by targeting a specific protein.
  • People who have previously used a BCMAxCD3 bispecific antibody, a type of medicine that works by connecting cancer cells to immune cells to help kill the cancer.
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Investigated drugs

  • Linvoseltamab

    is a targeted therapy used in this study to treat multiple myeloma. It works as a bispecific antibody, which means it is designed to attach to two different targets at once to help the body's immune system find and attack cancer cells.

  • REGN17372

    is an experimental therapy being tested in this study. Similar to the other treatment, it is a bispecific antibody designed to connect different components of the immune system to help fight cancer cells in patients with multiple myeloma.

What is already known about the treatment

  • Paracetamol

    This medication is taken orally in tablet form to relieve mild to moderate pain and reduce fever. It is a widely used and well-established drug that works by blocking certain chemical messengers in the brain that signal pain and regulate body temperature. It is classified as an analgesic and antipyretic.

  • Diphenhydramine hydrochloride

    This medication can be administered orally as a tablet or through an intravenous injection. It is commonly used to treat allergy symptoms and is also known for its ability to help with sleep or motion sickness. It works by blocking histamine, a natural substance in the body that causes allergic reactions, and is classified as an antihistamine.

  • Linvoseltamab

    This is an experimental drug administered through an intravenous infusion to treat certain types of blood cancer. It is currently being studied in clinical trials to see how well it can target cancer cells. This drug is a bispecific antibody that works by connecting immune cells directly to cancer cells to help the body destroy the tumor, classifying it as an immunotherapy.

  • Dexamethasone

    This medication is given through an intravenous injection or infusion to reduce inflammation and suppress the immune system. It is a long-standing treatment used for various inflammatory conditions and certain types of cancer. It works by mimicking the effects of natural hormones in the body to calm down the immune response and is classified as a corticosteroid.

  • REGN17372

    This is an experimental therapy administered via intravenous infusion for the treatment of relapsed or refractory multiple myeloma. It is currently in the early stages of clinical testing to evaluate its safety and effectiveness. As a bispecific antibody, it works by simultaneously binding to a specific protein on cancer cells and a protein on immune cells to trigger a targeted attack against the tumor.

Investigated diseases

Relapsed/Refractory Multiple Myeloma - This is a type of blood cancer that begins in the plasma cells, which are a type of white blood cell. In this condition, abnormal plasma cells grow uncontrollably in the bone marrow. The term relapsed refers to the cancer returning after a period of improvement. Refractory means the cancer continues to grow or does not respond to treatments. As the disease progresses, the abnormal cells can crowd out healthy blood cells and affect bone strength.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522776-93-00Protocol codeR17372-HM-2493Estimated enrolment99 patientsSponsorRegeneron Pharmaceuticals Inc.

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