AuthorisedTherapeutic exploratory (Phase II)Interventional

A SINGLE-ARM, OPEN-LABEL, PHASE II STUDY TO DETERMINE THE SAFETY AND EFFICACY OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN PARTICIPANTS WITH SEVERE, REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS WITH ACTIVE LUPUS NEPHRITIS

This study is testing a new treatment called obe-cel for people with a serious form of lupus that affects their kidneys (lupus nephritis). Lupus can cause the body's immune system to attack its own tissues, including the kidneys. We want to find out how well obe-cel works to improve kidney function and reduce other lupus symptoms. We'll also be carefully checking for any side effects to make sure the treatment is safe. The study is open to adults aged 18 and older who have not responded well to usual treatments. This is an important step in finding better ways to manage severe lupus and help people live healthier lives.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Autolus Limited

Enrolment target

Start

20 Nov 2025

Systemic Lupus Erythematosus with Active Lupus Nephritis

What is this study about?

This study is looking into a new treatment called obe-cel for a serious condition called systemic lupus erythematosus, or lupus for short. Lupus is an autoimmune disease, which means your body's immune system mistakenly attacks healthy cells and tissues. In this study, we are focusing on people whose lupus has severely affected their kidneys, a condition known as lupus nephritis. This can lead to serious kidney damage if not controlled.

The main goal of this study is to see how effective obe-cel is at improving kidney health and generally helping people with severe lupus. We'll be looking carefully at things like how well the kidneys are working and whether lupus symptoms improve. We also want to understand if obe-cel is safe to use and what side effects might occur. For this, different tests will be carried out over several months to monitor participants' health closely.

This is a 'Phase II' study, which means obe-cel has already been tested in earlier stages and shown some promise. This phase helps us gather more information about its safety and how well it works in a larger group of people. The information we learn from this study will be crucial in potentially making this new treatment available to more people with severe lupus in the future.

Key takeaways

This study is for adults with severe lupus affecting their kidneys.
It tests a new treatment called obe-cel to see if it helps improve kidney health and lupus symptoms.
The study also carefully checks for side effects and how safe the treatment is.
Participation involves regular clinic visits for tests and monitoring over up to two years.
It's an opportunity to access a potential new treatment not yet widely available.

Who may be eligible?

To join this study, you would need to be 18 years old or older. The study is open to both men and women.

Key to being considered for this study is having severe lupus that hasn't responded to other treatments and specifically affects your kidneys, causing what is called active lupus nephritis.

The study team will need to check your medical history and conduct some tests to make sure that taking part in the study is right for you and that you meet all the specific health requirements.

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 severe lupus?
Does your lupus actively affect your kidneys?
Has your lupus not responded well to other treatments you've tried?
Are you willing to attend regular clinic visits for up to two years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study treatment, obe-cel. This treatment involves a type of cell therapy, and you would also receive other medicines like Cyclophosphamide and Fludara, which are often used to prepare your body for such treatments.

Over the course of the study, which could last up to 24 months (2 years), you would have regular visits to the clinic. During these visits, the study team would perform various assessments. This includes blood tests, urine tests to check your kidney function, and possibly other tests to monitor your lupus and overall health. They will also ask you questions about how you are feeling and any new symptoms.

These regular checks are important to see how well the treatment is working and to make sure you are safe. The team will be monitoring for any side effects and changes in your condition.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment for your severe lupus that hasn't been widely available. This treatment might help improve your kidney function and other lupus symptoms. However, as with any new treatment, there are potential risks and side effects that the study team will discuss with you in detail. These can include reactions to the medicines, and the study will carefully monitor for any issues. 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 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
Greece

Common questions

What is 'lupus nephritis'?

Lupus nephritis is when lupus specifically affects your kidneys, making them inflamed and potentially damaging them. This can stop them from working properly.

What is obe-cel?

Obe-cel is a new type of treatment being tested for severe lupus that involves using special cells to help your immune system work better.

How long will the study last?

The study could last for up to 24 months, which is about two years, with regular check-ups during that time.

Will I still receive my usual lupus treatment?

The study involves a new treatment, and the study team will explain how this fits with your current care. You will also receive other medications to prepare you for the new treatment.

What are the main things the study is looking for?

The study wants to see if obe-cel helps improve kidney function and overall lupus symptoms, and to carefully check if it is safe to use.