RecruitingPHASE1, PHASE2INTERVENTIONAL

MB-CART19.1 in Refractory SLE

This research is looking at a new treatment called MB-CART19.1 for a condition called Systemic Lupus Erythematosus (SLE), often known simply as lupus. Lupus is a long-term illness where your immune system, which normally fights off infections, attacks your own body. This study is for people whose lupus is very severe and hasn't improved with other standard treatments. It's an early-stage trial (Phase 1/2), meaning it's one of the first times this treatment is being tested in humans. The main goals are to find out if the treatment is safe, to understand what dose works best, and to see if it helps improve lupus symptoms. Participants will be closely monitored to check for any side effects and how well the treatment is working over a long period.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Miltenyi Biomedicine GmbH

Enrolment target

Start

12 Aug 2024

Estimated completion

30 Sep 2027

SLE - Systemic Lupus Erythematosus

What is this study about?

This study is exploring a new treatment option for people living with Systemic Lupus Erythematosus (SLE), commonly known as lupus. Lupus is a complex illness where your body's defence system mistakenly attacks your own healthy tissues and organs. This can lead to a wide range of symptoms affecting many parts of the body, such as joints, skin, kidneys, heart, and lungs. While there are treatments available for lupus, some people find their condition remains very active and difficult to manage, even after trying several different medicines. This is what we call 'refractory' lupus.

The new treatment being tested is called MB-CART19.1. It's a type of treatment that uses your own immune cells, specially modified in a laboratory, to target specific cells that are thought to be involved in lupus. The aim is to calm down the overactive immune system in people with severe lupus. Because this is a new treatment, the study is in its early stages (called Phase 1 and Phase 2), which means the main focus is on making sure it's safe for people and figuring out the best dose to use. Researchers will also be carefully watching to see if the treatment helps improve symptoms of lupus.

Taking part in a study like this helps doctors learn more about diseases and discover new ways to help patients. While this specific treatment is new, early research helps pave the way for potential future treatments. Participants will be looked after very carefully by a team of doctors and nurses, and their health will be monitored closely throughout the study.

Key takeaways

This study is for severe lupus not helped by other treatments.
It's testing a new 'cell-based' treatment called MB-CART19.1.
The main goals are to check safety and find the best dose.
Participants will be closely monitored for many years.
It's an early-stage study, so benefits are not guaranteed.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. Your lupus must meet specific criteria, meaning it has to be severe and hasn't responded well to at least two other common lupus treatments like MMF, cyclophosphamide, or rituximab. Importantly, your lupus must be affecting major organs, such as your kidneys, heart, or lungs, in a significant way.

There are also some health conditions that would mean you couldn't join the study. For example, if you have certain severe problems with your brain or nervous system, uncontrolled diabetes, or if you've recently had therapy-related health issues, you might not be suitable. It’s also important that women who could become pregnant use effective contraception during and for some time after the study treatment.

All participants must also have received their COVID-19 vaccinations (or had a recent infection). These rules are in place to make sure the study is as safe as possible for everyone involved and to ensure the treatment is being tested on the most appropriate patients.

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?
Has your lupus been severe and not improved with at least two other main treatments?
Is your lupus affecting major organs like your kidneys, heart, or lungs?
Do you have a clear understanding of the study and are willing to sign an informed consent form?
Are you able to use reliable contraception if you could become pregnant?
Have you been fully vaccinated against COVID-19 or had a recent infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you're suitable. Once you're accepted, you'll receive the MB-CART19.1 treatment. After the treatment, you'll be monitored very closely for about a month, which will involve regular checks of your vital signs (like blood pressure and heart rate) and blood tests, mostly for safety reasons and to see how the treatment is affecting you. You might need to stay in hospital for some of this time.

After this initial intensive period, you'll continue to have regular follow-up visits, blood tests, and health checks for a full year. During this time, the medical team will keep a close eye on how your lupus is doing and check for any side effects. Even after a year, your health will continue to be monitored for another year, and then potentially for up to 13 more years. This long-term follow-up is really important to understand the full effects of such a new treatment. The total duration of your involvement could therefore be very long, depending on how long you remain in follow-up.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of trying a new treatment for your lupus that hasn't responded to standard therapies. It also contributes to medical knowledge, which could help others with lupus in the future. However, there are potential risks, as this is a new treatment. You might experience side effects, some of which could be serious, and the treatment might not work for you. The study team will explain all known and potential risks in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Universitätsklinikum Erlangen, Medizinische Klinik 3
Verified postcode
Erlangen, Germany· Not yet recruiting
Otto-von-Guericke-Universität Magdeburg
Verified postcode
Magdeburg, Germany· Recruiting
Universitatsklinikum Tubingen - Medizinische Universitätsklinik Abt. II
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is lupus?

Lupus is a long-term condition where your body's immune system mistakenly attacks your own healthy tissues and organs, leading to inflammation and various symptoms throughout the body.

What does 'refractory' lupus mean?

It means your lupus is severe and hasn't improved adequately even after trying several standard treatments.

What is MB-CART19.1?

It's a new type of treatment being tested that uses special modified cells from your own immune system to help control lupus.

How long will I be followed after the treatment?

You will be followed closely for about a month, then regularly for a year, and possibly for up to 14 years in total to see the long-term effects.

What if I don't want to continue in the study?

You are free to leave the study at any time, for any reason, and this will not affect your regular medical care.

How to find out more

Clinical Trial Manager

clinicaltrials.gov@miltenyi.com +4922048306820 Official trial record

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