RecruitingPHASE1, PHASE2INTERVENTIONAL

A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)

This study is investigating a new medicine, linvoseltamab, for adults with a rare blood condition called AL amyloidosis. This condition happens when abnormal proteins build up in organs. We are looking for people whose AL amyloidosis has returned or hasn't responded to previous treatments. The study has two main parts: first, we'll give the medicine to a small group to check for side effects and find the best dose. Then, in the second part, more people will receive the medicine to further assess its safety and see how well it treats AL amyloidosis. We'll also check if it improves organ problems and track how the medicine affects the body over time.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Regeneron Pharmaceuticals

Enrolment target

220

Start

07 Aug 2024

Estimated completion

20 Feb 2035

Relapsed/Refractory Systemic Light Chain Amyloidosis

What is this study about?

This research study is looking at a new medicine called linvoseltamab. It's for adults who have a condition known as AL amyloidosis. In AL amyloidosis, the body makes abnormal proteins that can build up in different organs, like the heart or kidneys, and stop them from working properly. We are specifically looking for people whose AL amyloidosis has either come back after treatment or hasn't improved with other medicines they've tried in the past.

The study is split into two main sections. In the first section, a small group of people will receive linvoseltamab. The main goal here is to carefully watch for any side effects and work out the safest and most effective amount of the medicine to give. This helps us decide what dose to use for the next part of the study.

Once we have a better idea of the right dose, more people will join the second section of the study. In this part, we'll continue to look closely at any side effects. More importantly, we'll also be checking how well linvoseltamab actually treats AL amyloidosis. We'll be looking to see if it helps to get rid of those abnormal proteins and if it improves how organs like the heart and kidneys are working.

Key takeaways

This study is testing a new medicine (linvoseltamab) for AL amyloidosis.
It's for people whose AL amyloidosis has returned or hasn't responded to other treatments.
The study aims to check if the medicine is safe and if it helps improve the condition.
Participation involves regular visits, blood tests, and scans.
You will be closely monitored for any side effects.
Your decision to join or leave the study is entirely up to you.

Who may be eligible?

To join this study, you must have a confirmed diagnosis of AL amyloidosis. Your doctor must also agree that you need more treatment, and you should have already tried at least one other treatment for your condition. We'll also need to check your blood tests to make sure your heart, liver, kidneys, and blood counts are generally working well.

There are also some reasons why you might not be able to join. For example, if you have a different type of amyloidosis, like one that isn't AL amyloidosis, this study wouldn't be right for you. Also, if you have certain bone problems or a very recent heart attack, you likely wouldn't be able to take part. The study also has rules about recent infections that needed a hospital stay or strong IV antibiotics.

Finally, a doctor will check a sample of your bone marrow; if too many certain cells are found, you might not be able to participate. Your study doctor will go through all these details with you to see if the study is a good fit.

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.

Do you have a firm diagnosis of AL amyloidosis?
Has your AL amyloidosis come back or isn't responding to your current treatments?
Are you aged 18 or older?
Have you been told you don't have certain other types of health issues, like a very recent heart attack or certain bone problems?
Are you able to manage clinic visits and assessments?
Are your heart, kidney, and liver functions generally healthy enough for a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study medicine, linvoseltamab. The study runs in two phases. In the first phase, a small group of participants will receive different doses to help us understand side effects and find the best dose. In the second phase, more participants will receive the identified dose. Throughout your time in the study, you will have regular visits to the clinic for various assessments, which will include blood tests and heart or kidney checks, to see how you are responding to the medicine and to monitor for any side effects. The study team will provide detailed information about the schedule of visits and what each visit will involve. Your participation will last for an amount of time determined by the study's progress and your individual response, but the team will explain the expected total duration.

Potential risks and benefits

Like all medicines, linvoseltamab might have side effects, and we will closely monitor you for any. These could make you feel unwell, but the study team will be there to support you. It's important to know that new medicines don't always work as hoped, but there is a chance it could help improve your condition, specifically by reducing the abnormal proteins that cause organ damage. Taking part means you'll be contributing to medical research that could help others with AL amyloidosis in the future. You are always in control of your decision and can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

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

City of Hope
Verified postcode
Duarte, United States· Recruiting
Colorado Blood Cancer Institute/SCRI
Verified postcode
Denver, United States· Recruiting
Karmanos Cancer Institute
Verified postcode
Detroit, United States· Recruiting
Roswell Park Comprehensive Cancer Center
Verified postcode
Buffalo, United States· Recruiting
Ohio State University
Verified postcode
Columbus, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
National and Kapodistrian University of Athens
Verified postcode
Athens, Greece· Recruiting
Seoul National University Hospital
Verified postcode
Seoul, South Korea· Recruiting
Asan Medical Center
Verified postcode
Seoul, South Korea· Recruiting
Samsung Medical Center
Verified postcode
Seoul, South Korea· Recruiting
Seoul St. Mary's Hospital - The Catholic University of Korea
Verified postcode
Seoul, South Korea· Recruiting

Common questions

What is AL amyloidosis?

It's a rare condition where abnormal proteins build up in your organs and can stop them from working properly.

What is linvoseltamab?

It's a new, experimental medicine being tested in this study to see if it can treat AL amyloidosis.

Why is this study only for people whose AL amyloidosis has come back?

This study focuses on people who haven't been helped by other treatments or whose condition has returned, as it's a specific area of need.

Will I definitely get the new medicine?

Yes, everyone in this study will receive linvoseltamab, as we are trying to learn about this specific treatment.

How long will I be in the study?

The exact length varies; the study team will tell you the expected duration and what to expect during regular check-ups.

How to find out more

Clinical Trials Administrator

clinicaltrials@regeneron.com 844-734-6643 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.