AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in participants with B-cell driven ARD.

This is a very early study, called a Phase 1 trial, looking into a new treatment for Systemic Lupus Erythematosus (SLE). SLE is a condition where the body's immune system mistakenly attacks its own healthy tissues. The new medicine is designed to target specific cells in the body (called B-cells) that are thought to play a role in SLE. Researchers want to find out if this new medicine is safe for people to take and how much of it stays in the body over time. They also want to see how the body reacts to the medicine and if it starts to work. The study is open to adults aged 18 and over, with both men and women being able to take part.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

23 Mar 2026

Systemic Lupus Erythematosus

What is this study about?

This study is about exploring a new potential treatment for a condition called Systemic Lupus Erythematosus, often shortened to SLE or just lupus. Lupus is an autoimmune disease, which means the body's own immune system, which normally fights off infections, starts attacking healthy parts of the body instead. This can cause inflammation and damage to many different organs and tissues, leading to various symptoms like joint pain, fatigue, skin rashes, and kidney problems.

The new medicine being tested in this study is designed to target specific cells in the body called B-cells. In conditions like lupus, these B-cells can sometimes become overactive and contribute to the immune system attacking the body. By targeting these cells, the researchers hope to calm down the overactive immune system and help improve the symptoms of lupus.

This is a very early-stage study, often called a 'Phase 1' study. At this stage, the main goal is simply to find out if the new medicine is safe for people to take. Researchers will also be looking at how the medicine moves through the body (how it's absorbed, distributed, and removed) and how the body's immune system reacts to it. It's an important step in understanding whether this new treatment might be helpful for people with lupus in the future.

Key takeaways

This is an early-stage (Phase 1) study for Systemic Lupus Erythematosus (SLE).
It's testing a new medicine designed to target specific immune cells (B-cells).
The main goals are to check the medicine's safety and how it works in the body.
Participation is for adults aged 18 and over, both men and women.
You'll need regular clinic visits and tests if you join.
You can stop participating at any time without affecting your NHS care.

Who may be eligible?

To join this study, participants need to be adults, aged 18 years or older. This study is open to both men and women.

Because this is an early-stage study for Systemic Lupus Erythematosus, there will be specific health requirements determined by the study doctors. These are put in place to help make sure the study is safe for everyone involved and that the results are clear.

You would not be able to join if you have certain other medical conditions or if you are taking specific medications that might interfere with the new treatment. A doctor involved in the study will discuss all these details with you to see if your health condition is right for taking part.

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.

Am I 18 years old or older?
Have I been diagnosed with Systemic Lupus Erythematosus (SLE)?
Am I generally able to attend regular clinic appointments?
Am I open to taking a new, experimental medicine?
Do I have any other major health conditions or take other specific medications that might exclude me?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the new study medicine according to a set schedule. This is a very early study, so it will involve regular visits to the clinic for check-ups. These visits will include health assessments like blood tests to monitor your safety and how the medicine is affecting your body, and possibly other tests related to your lupus condition.

The study will also involve follow-up appointments after you've finished taking the medication to make sure you are well and to check on any lasting effects. The total duration of your involvement, including all treatments and follow-up, will be explained in full by the study team. It's important to understand that early-stage studies often have more frequent visits and tests than later-stage studies.

Potential risks and benefits

Potential benefits of taking part could include gaining early access to a new treatment that might help with your lupus, although this isn't guaranteed. You would also be contributing valuable information that could help others with lupus in the future. As with any new medicine, there are potential risks, including side effects that are not yet fully known. These will be carefully monitored by the study team, and you will be given more detailed information. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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
France
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Unverified
Italy
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Unverified
Spain
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Unverified
Poland

Common questions

What does 'CD19/CD20 T-cell engager' mean?

It's a fancy name for a new type of medicine. It's designed to help your body's immune cells (`T-cells`) find and remove other specific cells (`B-cells`) that might be causing problems in lupus.

What is 'Human Pharmacology (Phase I) - Other'?

This means it's a very early study on humans, the first time this medicine is being tested. The main goal is to check how safe it is and how it works in the body, rather than focusing on how well it treats the disease yet.

What does 'B-cell driven ARD' refer to?

ARD stands for Autoimmune Rheumatic Disease. 'B-cell driven' means that doctors believe specific cells called B-cells are playing a big role in causing the immune system to attack itself in conditions like lupus.

Will this medicine cure my lupus?

It's too early to say if this new medicine could cure lupus. This study is mainly about checking its safety. If it proves safe, future studies will look into how well it treats the disease.

Can I still take my regular lupus medication if I join?

This will depend on the study's rules. Some studies allow you to continue your usual medicines, while others might ask you to stop or change them. The study team will discuss this clearly with you.