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RecruitingPHASE1INTERVENTIONAL

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

This study is looking at a new treatment called obe-cel for people with severe lupus (Systemic Lupus Erythematosus) that hasn't responded to other treatments. Obe-cel is a type of 'CAR T-cell therapy' where a patient's own immune cells are specially trained to fight lupus. This is a very early stage (Phase 1) study in the UK and aims to discover if obe-cel is safe, what side effects it might have, and if it shows any signs of helping people with lupus. Researchers also want to find the right dose. Only a small number of adults and teenagers with lupus will take part.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Autolus Limited
Enrolment target
18
Start
02 Feb 2024
Estimated completion
01 Sep 2027

What is this study about?

This study is about a new and experimental treatment called obe-cel for severe Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term autoimmune condition that can cause inflammation and damage to many parts of the body. For some people, lupus is very severe and doesn't respond well to standard treatments. This study aims to find a new option for them.

Obe-cel is a type of 'CAR T-cell therapy'. In simple terms, this means that some of a person's own immune cells (T-cells) are taken from their body, specially changed in a lab to target specific cells linked to lupus, and then given back to the patient. The idea is that these modified cells will then help fight the lupus.

This is a 'Phase 1' study, which means it's an early stage trial. The main goals are to check if the treatment is safe, what side effects it might have, and to get an early idea of whether it could be an effective treatment for severe lupus. Researchers will also be looking for the best dose to use in future studies. Because it's an early study, only a small number of people will be involved.

Key takeaways

  • This is an early-stage study for severe lupus.
  • It's testing a new 'CAR T-cell' treatment called obe-cel.
  • The main aim is to check safety and potential effectiveness.
  • Open to teenagers (12+) and adults in the UK with severe, uncontrolled lupus.
  • Participation involves special cell collection and treatment.

Who may be eligible?

This study is looking for both adults and teenagers with severe lupus to take part, specifically those aged 12 to 65 years old who are in the UK. To be considered, you must have a formal diagnosis of lupus that meets specific criteria, and your lupus must be considered severe and not responding to other treatments. You'd also need certain markers in your blood, like specific antibodies, that are typical of lupus.

There are also reasons why you might not be able to join. For example, if you've recently had certain lupus treatments or other cell therapies, or if you've had certain vaccines recently. If you have severe lupus affecting your brain that has come back often, or if your lupus has caused severe, lasting organ damage that doctors believe can't be helped by this treatment, you might not be eligible. Also, if you have other severe autoimmune diseases or a history of certain serious brain conditions, you wouldn't be able to participate.

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.

  1. Are you between 12 and 65 years old and living in the UK?
  2. Have you been diagnosed with severe lupus that hasn't responded to other treatments?
  3. Do your medical records show specific lupus-related blood markers?
  4. Have you avoided certain lupus medications or other cell therapies recently?
  5. Are you free from other serious autoimmune diseases or severe, unstable brain conditions?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves isn't fully explained here. However, generally in a study like this, you would first go through screening tests to see if you meet all the requirements. If you do, you would then have a process called 'leukapheresis' where some of your blood is taken, and your T-cells are separated out to be specially prepared in a lab. After a period of time, the special obe-cel treatment would be given back to you through a drip. You would likely need to stay in hospital for a period after the treatment for close monitoring. You would also have regular follow-up appointments, blood tests, and scans over potentially a long period to check on your health and how the treatment is working. The total duration of the study is not specified but early stage cell therapy studies often involve long-term follow-up.

Potential risks and benefits

As with any new treatment, there are potential benefits and risks to consider. The potential benefit is that obe-cel might help to control severe lupus that hasn't responded to other treatments, potentially improving your health and quality of life. However, because this is a new and early-stage treatment, there's always a risk of unexpected side effects, which could be serious. Researchers will be carefully monitoring all participants for any adverse reactions. You will be given full information about all known and potential risks before you decide to join. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Hospital Universitari Vall Hebrón
    Verified postcode
    Barcelona, Spain· Recruiting
  • Hospital Universitari i Politecnic La Fe
    Verified postcode
    Valencia, Spain· Recruiting
  • Addenbrookes Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • University College London Hospitals NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Great Ormond Street Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Manchester Royal Infirmary, Manchester University NHS Foundation Trust,
    Verified postcode
    Manchester, United Kingdom· Recruiting

Common questions

What is lupus?

Lupus (Systemic Lupus Erythematosus) is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues, causing inflammation and damage in many parts of the body.

What is obe-cel?

Obe-cel is a new, experimental cell therapy. It involves taking your own immune cells, modifying them in a lab to target lupus, and then giving them back to you.

What does 'severe, refractory' lupus mean?

It means your lupus is very serious and hasn't responded well to the usual treatments, making it difficult to control.

Is this treatment approved for lupus?

No, this is an early-stage study (Phase 1), meaning it's still being tested to see if it's safe and effective. It is not an approved treatment.

Will I get the active treatment or a placebo?

This is a single-arm study, meaning all participants will receive the obe-cel treatment. There is no placebo group.

How to find out more

Autolus Limited

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

Interested in taking part?

Register your interest

Share your details and the research team for "Obe-cel in Adolescent [Applicable in UK Only] and Adult Seve…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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