AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2, Open-Label, Randomized, Multicenter Study of KYV101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis (KYSA-7)

This study, called KYSA-7, is looking at a new treatment for primary or secondary progressive multiple sclerosis (MS) that hasn't responded well to other therapies. The new treatment, KYV101, is a type of 'CAR T-cell' therapy, which uses your own specially modified immune cells to fight the disease. The study will compare KYV101 with standard MS medications like Kesimpta, Ocrevus, MabThera, and Briumvi. Researchers want to see if KYV101 can slow down MS progression, improve disability, and reduce flair-ups, all while checking for any side effects. It's a key step in understanding if this innovative approach could offer new hope for people living with progressive MS.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Kyverna Therapeutics Inc.

Enrolment target

Start

01 Oct 2024

Primary or Secondary Progressive Multiple Sclerosis

What is this study about?

This study is for people in the UK who have a type of multiple sclerosis (MS) called primary or secondary progressive MS. This means your MS symptoms are steadily getting worse, or have been getting worse after an initial period of relapses and remissions. Often, these forms of MS are more challenging to treat, and current medications may not be stopping the progression enough.

The main goal of this study is to test a new treatment called KYV101. This is a very advanced type of treatment where doctors take some of your own immune cells (a type of white blood cell called a T-cell), modify them in a lab to make them better at fighting certain cells linked to MS, and then put them back into your body. This treatment is called 'CAR T-cell therapy'. The study wants to see how well KYV101 works compared to some existing MS medications like Kesimpta, Ocrevus, MabThera, and Briumvi, and also to check for any side effects.

Researchers will be looking closely at how the treatment affects your disability, such as walking and daily activities, using standard MS scoring systems. They will also check if it reduces MS flair-ups, how it affects your brain through MRI scans, and track the number of the special CAR T-cells in your body. This research is important because it could lead to new ways to treat progressive MS, potentially offering a new option for people who haven't found enough relief from current therapies.

Key takeaways

This study is for adults with progressive MS that's getting worse.
It's comparing a new cell therapy (KYV101) with existing MS drugs.
Participation involves close monitoring, including regular check-ups and MRI scans.
You might receive the new treatment or a standard MS medication.
The goal is to find better ways to treat progressive MS.

Who may be eligible?

This study is open to both men and women aged 18 and older. To be considered, you must have a confirmed diagnosis of either primary progressive multiple sclerosis or secondary progressive multiple sclerosis. It's important that your doctors have noticed your disability getting worse.

You would not be eligible if your MS is in an early stage or if you have a relapsing-remitting form of MS that is currently stable. The study is specifically looking for people whose progressive MS has not responded well to other treatments, suggesting a more active or difficult-to-manage form of the condition.

There might be other health conditions or medications that would prevent you from joining, as the researchers need to ensure the study is safe for everyone involved. Your MS specialist will be able to review all the detailed requirements with you to see if this study could be a possibility.

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 primary or secondary progressive MS?
Has your disability due to MS been getting steadily worse?
Are you able to attend regular clinic visits and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the new KYV101 treatment or one of the existing MS medications (Kesimpta, Ocrevus, MabThera, or Briumvi). This means you won't get to choose which treatment you receive; it's decided by chance, like flipping a coin. You will have regular visits to the clinic for medical check-ups, blood tests, and MRI scans of your brain. Doctors will carefully monitor your health and how your MS is progressing. You'll be asked to report any new symptoms or side effects you experience.

Your participation will involve multiple assessments to measure your disability, brain changes, and how your body reacts to the treatment. The total duration of your participation in the study, including follow-up, will be determined by the study design, but generally, these types of trials can last for several years to fully understand the long-term effects of the treatments. More specific details about the number of visits and exact tests will be provided by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new experimental treatment that could potentially slow down your MS progression, or from closely monitored care from MS specialists. However, there are risks involved with any medication, including potential side effects from the study treatments. The new cell therapy (KYV101) is a complex treatment and could have different or more severe side effects than standard medications. You will be closely monitored for any adverse reactions throughout the study. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Germany
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Unverified
Italy
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Unverified
Belgium
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Unverified
Austria

Common questions

What is 'progressive MS'?

Progressive MS is a type of multiple sclerosis where your symptoms gradually worsen over time, rather than coming and going in attacks.

What is 'CAR T-cell therapy'?

It's a special treatment that uses your own immune cells, which are modified in a lab to better fight certain medical conditions, then put back into your body.

Will I definitely get the new treatment if I join?

No, you'll be randomly assigned to either receive the new treatment (KYV101) or one of the existing MS medications. It's like drawing lots.

What will doctors be looking for in the study?

They'll be checking if the treatments slow down your MS, improve your daily abilities, reduce flair-ups, and if there are any side effects, using various tests like MRI scans.

Can I stop participating in the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your regular medical care.