AuthorisedTherapeutic confirmatory (Phase III)Interventional

HO183 CAR T: A phase III randomized trial comparing academically produced BCMA-directed CAR T-cells (ARI0002h) with standard of care regimen in patients with relapsed/refractory multiple myeloma

This important study is looking for better ways to treat multiple myeloma, a type of blood cancer, when it has returned or hasn't responded to earlier treatments. It compares a special type of cell therapy, called CAR T-cells (specifically ARI0002h), with treatments that are currently used. CAR T-cells use a person's own immune cells, modified in a lab, to find and kill cancer cells. The main goal is to see if ARI0002h CAR T-cells can help patients live longer without their cancer getting worse, compared to existing treatments. Researchers will also look at how safe the new therapy is, how well it works, and its impact on a person's quality of life.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

126

Start

29 Apr 2026

relapsed/refractory multiple myeloma

What is this study about?

This study is a Phase III clinical trial, which means it's one of the final steps in testing a new treatment – in this case, a special type of cell therapy called ARI0002h CAR T-cells. We're looking at adults with multiple myeloma, a blood cancer, that has either come back after previous treatments or hasn't responded well to them. This is a difficult situation, and we want to find more effective options for these patients.

The trial compares this new CAR T-cell therapy with treatments that are currently considered standard care. CAR T-cell therapy is a truly innovative approach where a patient's own white blood cells are collected, sent to a lab, and then modified to better recognise and fight their cancer. These 're-engineered' cells are then given back to the patient. The aim is to see if this new ARI0002h CAR T-cell therapy can improve how long patients live without their cancer getting worse, compared to what we currently offer.

Beyond simply extending the time patients live without their cancer progressing, the study will also carefully check how safe the CAR T-cell therapy is and what side effects might occur. We'll also be looking at how well the cancer responds to treatment, if the cancer completely disappears, and how it affects patients' overall quality of life. This research is crucial in helping us understand if this new treatment could become a valuable option for future patients struggling with relapsed or refractory multiple myeloma.

Key takeaways

Tests a new CAR T-cell therapy (ARI0002h) for multiple myeloma.
Compares it to standard existing treatments.
Focused on multiple myeloma that has returned or not responded to previous therapies.
Main goal: See if the new treatment helps patients live longer without their cancer getting worse.
Also examines safety, side effects, and quality of life.
For adults aged 18 and over.

Who may be eligible?

This study is designed for adults, aged 18 and over, who have been diagnosed with multiple myeloma. The 'relapsed/refractory' part means that your multiple myeloma has either returned after you've had previous treatments, or it hasn't responded to the treatments you've received so far.

To join, you would need to meet certain health criteria, which the study team would check very carefully. This includes ensuring your other organs are working well enough and that you haven't received certain other treatments too recently. The medical team will review your full medical history to confirm if this study might be suitable for you.

Both men and women can take part in this study. The team will explain all the specific requirements in detail and answer any questions you might have about whether you can join.

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 hasn't responded well to previous treatments?
Are you able to attend regular hospital visits for check-ups and treatments?
Are you willing to potentially receive either the new cell therapy or a standard treatment without choosing?
Do you have suitable general health, as confirmed by medical tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure it's the right fit for you. If you qualify, you would be randomly assigned to receive either the ARI0002h CAR T-cell therapy or a standard treatment regimen. This means you wouldn't get to choose which treatment you receive, to ensure a fair comparison.

For those receiving CAR T-cell therapy, your blood cells would be collected and sent away to be specially processed. During this time, you might receive some 'bridging' therapy to keep your myeloma controlled. Once the CAR T-cells are ready, you would have them infused back into your body. Both groups would have regular clinic visits for check-ups, blood tests, and imaging scans (like X-rays or CT scans) to monitor your health and how the treatment is working. These visits might involve taking medications as prescribed.

The follow-up period can be quite long to understand the full effects of the treatments, potentially lasting for several years, even after you've finished the main treatment. The study team will always explain the exact schedule of visits, tests, and medications specific to your group, and ensure you understand your commitment.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing an innovative treatment that might be more effective than current options, especially for a difficult-to-treat condition like relapsed/refractory multiple myeloma. However, all medical treatments, especially new ones, carry potential risks. The CAR T-cell therapy or the standard treatments might cause side effects, some of which could be serious. The study team will closely monitor you and explain all known or potential risks in detail. You are always 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
Netherlands

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 your bone marrow.

What does 'relapsed/refractory' mean?

It means the cancer has either returned after you've had treatment, or it hasn't responded well to previous treatments.

What are CAR T-cells?

CAR T-cells are a patient's own immune cells, specially modified in a lab, to help them recognise and fight cancer cells more effectively.

How long will the study last for me?

While the treatment phase might be shorter, follow-up will last for several years to track long-term effects. The study team will give you a detailed timeline.

Will I know which treatment I'm receiving?

No, participants are randomly assigned to either the new CAR T-cell therapy or a standard treatment to ensure a fair comparison. This is common in these types of studies.