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

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What is this study about?

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.

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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Evangelismos S.A. Athens Greece
Alexandra Hospital Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not yet recruiting
25.09.2026

Trial locations

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.

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 ID:
2025-522776-93-00
Protocol code:
R17372-HM-2493
Trial Phase:
Human Pharmacology (Phase I) – First administration to humans

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