RecruitingPhase IIInterventional

Testing a new treatment to prevent severe immune reactions in people with multiple myeloma taking teclistamab

This study is looking into a new way to make treatment safer for people with a type of blood cancer called multiple myeloma. If your myeloma has come back or isn't responding to other treatments, you might be taking a new medicine called teclistamab. While teclistamab can be very helpful by boosting your immune system to fight the cancer, it can sometimes cause a strong immune reaction called Cytokine Release Syndrome (CRS). This can lead to symptoms like fever or breathing issues. This trial will test a new oral drug, POLB 001, to see if it can prevent or reduce the severity of CRS when given alongside teclistamab. We want to find out if POLB 001 is safe and effective in helping people tolerate teclistamab better.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

DIDACT Foundation

Enrolment target

Start

29 Mar 2026

Estimated completion

30 Mar 2027

Medical condition: relapsed or refractory multiple myeloma (RRMM) Medical condition in lay language: Myeloma (blood cancer) Therapeutic areas: Diseases [C] - Cancer [C04]

What is this study about?

This study is focused on people who have multiple myeloma, a type of blood cancer. Specifically, it's for those whose myeloma has either returned after treatment or is no longer responding to their current medicines. These patients might be starting a treatment called teclistamab.

Teclistamab is a special type of medicine that helps your body's own immune system fight the cancer. It can be very effective, but it can also cause a side effect called 'cytokine release syndrome' (CRS). CRS happens when your immune system becomes too active and can make you feel unwell with symptoms like a fever, low blood pressure, or problems breathing. This study is testing a new pill, called POLB 001, to see if it can stop or reduce these strong immune reactions when taken before and during the early stages of teclistamab treatment.

The main goal of this study is to find out if POLB 001 is safe and whether it can prevent CRS or make it less severe. This could mean that teclistamab treatment becomes safer and easier to manage for people with multiple myeloma, helping them get the most benefit from their cancer treatment with fewer difficult side effects. Researchers will also look at how well teclistamab works for these patients and how POLB 001 behaves in the body.

Key takeaways

This study is testing a new medicine (POLB 001) to make multiple myeloma treatment (teclistamab) safer.
The goal is to prevent or reduce a strong immune reaction called Cytokine Release Syndrome (CRS).
Participation involves taking POLB 001 for 14 days, then continuing teclistamab for two months within the study.
You will be closely monitored for side effects and how your body responds.
The study aims to improve the safety of teclistamab treatment for current and future patients.
You will be in the study for approximately 3 months, then can continue teclistamab via the NHS.

Who may be eligible?

This study is open to adults aged 18 or older who have been diagnosed with multiple myeloma that has either returned or isn't responding to past treatments. To join, you must meet specific NHS guidelines for receiving teclistamab from your doctor. This usually means you've had at least three different treatments for your myeloma already, including particular types of drugs, and your cancer has shown signs of growing since your last treatment.

There are also some general health requirements to make sure it's safe for you to take part. This includes having good organ function (like your liver and kidneys) and a certain level of blood cells. You must also be able to take medicines by mouth.

You cannot join the study if you've had a similar type of antibody treatment before, or if you have certain rare forms of myeloma or specific other illnesses. Your doctor will check all these details to see if this study is right for you.

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?
Do you have multiple myeloma that has come back or isn't responding to past treatments?
Have you had at least three different treatments for your myeloma, including specific types of drugs?
Can you take medicines by mouth?
Are you able to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, about 30 patients will take part across six hospitals in the UK. You will receive the new medicine POLB 001 as a pill for 14 days, starting just before you have your first dose of teclistamab. You'll then continue taking teclistamab as part of the study for about two months (two cycles of treatment). After this, you would smoothly move to getting your teclistamab from the NHS, and you can continue with this treatment for as long as it's helping you.

Overall, you'll be part of the study for around three months. During this time, the medical team will keep a very close eye on you. They will monitor you for any side effects and specifically check for signs of that immune reaction called CRS. You'll have regular appointments, and they'll take blood and bone marrow samples to see how you're responding and if POLB 001 is safe. In some cases, if early results show that a higher dose of POLB 001 has side effects, some patients might receive a lower dose. The study aims to make your treatment as comfortable as possible, potentially allowing some visits to be outside of the hospital if your clinic offers this.

Potential risks and benefits

Participating in this study might offer you a benefit by potentially reducing the strong immune reactions (CRS) that can happen with teclistamab, making your treatment safer and possibly more comfortable. The new drug, POLB 001, has been tested in healthy people and seemed well-tolerated with no serious side effects reported, but as it's new, there could be unknown risks. You'll be watched very closely for any side effects, and treatments will be available if CRS occurs. However, there are also standard risks associated with blood tests, bone marrow samples, and scans like PET-CT or MRI, such as discomfort, bruising, or rarely, infection. Some specific side effects of POLB 001 could include temporary changes in liver readings, skin rashes, or dizziness, which are usually mild. Teclistamab itself carries risks like CRS. It's important to know that all study treatments can harm an unborn child, so effective contraception is required. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (4)

The Christie
Approximate
Manchester, England
University College London Hospitals
City only
London, England
The Royal Marsden Hospital
Approximate
London, England
Queen Elizabeth Hospital
Approximate
Birmingham, England

Common questions

What is multiple myeloma?

Multiple myeloma is a type of blood cancer that affects certain cells in your bone marrow.

What is teclistamab?

Teclistamab is a newer medicine that helps your body's immune system fight myeloma cells.

What is Cytokine Release Syndrome (CRS)?

CRS is an immune reaction that can make you feel unwell with symptoms like fever or breathing problems, which can happen with some cancer treatments.

What is POLB 001?

POLB 001 is a new oral drug being tested in this study to see if it can prevent or reduce CRS when given with teclistamab.

How long will I be in the study?

You will be in the study for about three months in total, after which your teclistamab treatment can continue through the NHS if it's working for you.

How to find out more

- Study Management

ACT-MM-001@act4patients.com - Official trial record

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