AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Clinical Study to Evaluate the Effects of Cevostamab in Patients with Lupus with or without Active Lupus Nephritis

This research study is looking into a new medicine called cevostamab for adults living with lupus. Lupus is a long-term condition that can affect many parts of the body. Some people with lupus also have kidney problems, known as lupus nephritis. This is a very early study (Phase 1), which means researchers want to find out how the medicine works in the body, what dose is best, and if it's safe for people to take. It's an important first step in developing new treatments. The study aims to help us understand more about how cevostamab might be able to help people with lupus, whether or not their kidneys are affected.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Genentech Inc.

Enrolment target

Start

22 Apr 2026

Systemic Lupus Erythematosus (SLE) With or Without Active Lupus Nephritis (LN)

What is this study about?

This study is looking at a new treatment called cevostamab for people who have Systemic Lupus Erythematosus (SLE), commonly known as lupus. Lupus is a condition where your body's immune system mistakenly attacks healthy tissues, which can cause inflammation and damage to many organs, including the skin, joints, kidneys, and brain. Some people with lupus also develop a specific kidney problem called lupus nephritis, which means their kidneys are inflamed.

The main goal of this study is to understand more about cevostamab. Researchers want to see how the medicine acts in the body, how much of it stays in the system, and how the body handles it. This is a "Phase 1" study, which means it's one of the first times this new medicine is being tested in humans. At this stage, the focus is on safety and figuring out the right dose, rather than on how well it treats the disease.

Finding new and effective treatments for lupus is very important because while there are existing medicines, they don't work for everyone or can have unpleasant side effects. By carefully studying new medicines like cevostamab, researchers hope to offer more options in the future that could improve the lives of people living with lupus, including those facing kidney complications.

Key takeaways

This study is for adults with lupus, including those with kidney issues (lupus nephritis).
It's a very early-stage study (Phase 1) focused on safety and understanding the new medicine.
The new medicine being tested is called cevostamab.
Taking part involves regular clinic visits for checks, like blood tests and examinations.
You can stop participating at any time without affecting your usual medical care.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women can take part. Researchers will check other health details to make sure the study is suitable and safe for everyone involved.

Essentially, the study is designed for adults who have a diagnosis of lupus (Systemic Lupus Erythematosus). It also includes people whose lupus has specifically affected their kidneys, a condition known as "active lupus nephritis."

The study team will carefully review your medical history and current health to determine if you meet all the necessary requirements to participate. This is to ensure your safety and that the study can gather accurate information.

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 a diagnosis of lupus (Systemic Lupus Erythematosus)?
Have you been told you have lupus that affects your kidneys (active lupus nephritis)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the experimental medicine, cevostamab, which is the treatment being tested. The study will involve several visits to the clinic, where the study team will carry out various checks. These checks might include blood tests, urine tests, physical examinations, and asking you about your health and how you are feeling. The exact number of visits and the full length of your participation will be explained in detail by the study team, as it varies depending on the study design. You will be closely monitored throughout the study to see how your body responds to the medicine and to keep an eye on your overall health.

Potential risks and benefits

Taking part in a clinical study means there could be potential benefits, such as helping researchers learn more about lupus and possibly leading to new treatments in the future. You might also gain access to a new medicine before it is widely available. However, there are also potential risks; the medicine might cause side effects, some of which could be serious or unexpected. You will be fully informed of all known and potential risks before you decide to join. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Italy
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Unverified
Spain
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Unverified
France
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Unverified
Germany

Common questions

What is lupus?

Lupus is a long-term condition where your immune system mistakenly attacks healthy tissues in your body. It can affect many organs, like your joints, skin, kidneys, and heart.

What is lupus nephritis?

Lupus nephritis is a specific kidney problem that can happen to some people with lupus. It means the kidneys become inflamed and don't work as well as they should.

What does 'Phase 1' study mean?

Phase 1 is the earliest stage of testing a new medicine in people. The main goals are to check if it's safe, understand how it works in the body, and find the right dose.

Will I get the actual medicine or a dummy treatment?

Because this is a Phase 1 study focused on safety, participants typically receive the study medicine (cevostamab). However, always ask the study team for details about your specific trial.

How long does a study like this usually last?

The total length of time you'd be involved in the study can vary. The study team will be able to tell you the exact duration based on their plan.