AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A FIRST-IN-HUMAN (FIH) PHASE 1/2 STUDY TO ASSESS SAFETY, TOLERABILITY, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF REGN17372, AN ANTI-GPRC5D X ANTI-CD28 COSTIMULATORY BISPECIFIC MONOCLONAL ANTIBODY, IN COMBINATION WITH LINVOSELTAMAB, AN ANTI-BCMA X ANTI-CD3 BISPECIFIC MONOCLONAL ANTIBODY, IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

This early-stage medical study is for people with multiple myeloma that has either returned after treatment or hasn't responded to previous therapies. Researchers are testing two new drug combinations: REGN17372 with linvoseltamab, and linvoseltamab on its own. The main goals are to find out if these combinations are safe, what side effects they might cause, and if they show any signs of shrinking the cancer or slowing its growth. This is a "first-in-human" study, meaning it's one of the first times these specific combinations are being given to people.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

22 Apr 2026

Relapsed/Refractory Multiple Myeloma

What is this study about?

This study is an early research project (called Phase 1/2) looking into new ways to treat multiple myeloma, a type of blood cancer. It's specifically for people whose multiple myeloma has either come back after previous treatments (we call this 'relapsed') or hasn't responded well to those treatments ('refractory'). The main aim is to see how safe a new medicine called REGN17372 is when given along with another drug called linvoseltamab. Researchers also want to see if linvoseltamab on its own is effective, and to compare these two options.

Think of it like this: your body has an immune system that helps fight off illness. For people with multiple myeloma, the immune system isn't always good at targeting cancer cells. The medicines being tested are a type of treatment called 'bispecific monoclonal antibodies'. These are specially designed to help your immune system recognise and attack the myeloma cells. They act a bit like a bridge, bringing immune cells closer to the cancer cells so they can fight them more effectively.

Because this is an early study, the main focus in the first part (Phase 1) is to carefully check for any serious side effects and to find the right dose. In the later part (Phase 2), if the medicines are found to be safe, researchers will look more closely at whether they can make the cancer shrink or stop growing. This study is an important step in developing new treatments for multiple myeloma.

Key takeaways

This is an early-stage study for relapsed or refractory multiple myeloma.
It tests new drug combinations, including REGN17372 and linvoseltamab.
The main goals are to check drug safety, side effects, and early signs of effectiveness.
Participants will receive study drugs via infusion and other supporting medicines.
Close medical monitoring and regular hospital visits are required.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. Both men and women can join.

The main requirement for this study is that you have multiple myeloma that has either returned after you've had treatment for it before, or it hasn't responded well to your past treatments. This is often referred to as 'relapsed/refractory' multiple myeloma.

There will also be other specific medical checks and tests to make sure that the study medicines are safe for you and that you meet all the health requirements to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with multiple myeloma?
Has your multiple myeloma come back after treatment, or not responded to previous treatments?
Are you willing to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be carefully monitored by the study team. This will involve regular visits to the hospital or clinic for check-ups, blood tests, and scans. The study medicines, REGN17372 and linvoseltamab, will be given through a drip (infusion).

You will also receive some other medications, such as paracetamol, diphenhydramine, and dexamethasone. These are often used to help manage any potential side effects of the study drugs. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing follow-up visits.

The study involves two main parts. In the first part, the doctors will be specifically looking for any side effects and finding the best dose. In the second part, they will monitor how well the treatment is working. Your health and progress will be tracked throughout the entire study.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as receiving new treatments before they are widely available. You'll also receive close medical attention and monitoring. However, there are also potential risks, including side effects from the study drugs that are not yet fully known. Some side effects might be mild, while others could be more serious. It's important to understand that the treatments might not work for everyone. If you choose to join, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Greece

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. These cells normally help fight infections. In multiple myeloma, they grow too much and can cause problems in the bones, kidneys, and blood.

What does 'relapsed/refractory' mean?

It means the cancer has either returned after previous treatments ('relapsed') or it hasn't responded well to those treatments ('refractory'), which means it continued to grow or got worse.

What is a 'first-in-human' study?

This means it's one of the first times these specific new drug combinations are being given to people. Researchers will be very careful to check safety and any early signs of benefit.

What are bispecific antibodies?

These are special proteins designed to attach to two different targets at the same time. In this study, they are designed to bring your immune cells closer to the cancer cells to help your body fight the myeloma.

Will I receive the new drug combination or only linvoseltamab?

The study is testing both options. Some participants will receive the combination of REGN17372 and linvoseltamab, while others will receive linvoseltamab on its own. Your doctor will explain which group you might be in.