RecruitingPHASE1, PHASE2INTERVENTIONAL

Controlling Hyperactive Immunity With Long-lived Lymphocytes

This study is testing a new experimental treatment called QEL-005 for adults with two serious autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (RA). The main aims are to find out if QEL-005 is safe, how well people tolerate it, and if it might reduce disease activity or improve symptoms. QEL-005 is made from a person's own white blood cells, which are collected and then specially changed in a lab. These modified cells are designed to help control the immune system and are given back to the participant through a drip. Researchers will closely monitor participants to understand how the treatment works and to determine the best dose for future studies.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Quell Therapeutics Limited

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Aug 2028

Diffuse Cutaneous Systemic Sclerosis Rheumatoid Arthritis (RA)Systemic Sclerosis (SSc)Autoimmune Rheumatologic Disease

What is this study about?

This study is looking into a new way to treat two difficult autoimmune conditions: diffuse cutaneous systemic sclerosis and a type of rheumatoid arthritis that hasn't responded well to other treatments. In these conditions, the body's immune system mistakenly attacks its own tissues, causing inflammation and damage. The experimental treatment, called QEL-005, aims to rebalance the immune system and hopefully reduce disease activity and improve symptoms.

QEL-005 is a special type of cell therapy. It's made by taking some of your own white blood cells, which are important parts of your immune system. These cells are then sent to a lab where they are carefully changed using genetic methods. The goal is to turn them into 'smart' cells that can help calm down the overactive parts of your immune system. Once modified, these personalised cells are given back to you through a drip in your vein.

This is an early-stage study (Phase 1/2), which means the researchers are mainly focused on checking if QEL-005 is safe for people to use and if it's well-tolerated. They will also be looking to see if there are any signs that it helps with symptoms or disease activity. The information gathered in this study will be crucial for deciding if QEL-005 can be studied further in larger groups of people and to work out the best way to give it.

Key takeaways

Tests a new treatment (QEL-005) for severe rheumatoid arthritis and systemic sclerosis.
Uses your own specially modified white blood cells to help control your immune system.
Main goals are to check safety, how well it's tolerated, and if it helps symptoms.
Involves a cell collection procedure and then a single treatment infusion.
Requires detailed follow-up for one year, and then longer-term monitoring for 15 years.
This is an early-stage study, so benefits are not guaranteed.

Who may be eligible?

To join this study, you must be at least 18 years old. You'll need to have either diffuse cutaneous systemic sclerosis which hasn't responded well to other treatments, or a type of rheumatoid arthritis that is considered difficult to treat. Your doctors will check if your condition meets all the specific criteria, including having signs of active disease and certain antibody levels.

There are also general health requirements, such as having good kidney, liver, and blood cell function. You also need to be willing to participate in a long-term follow-up for 15 years, which is common for this type of treatment. If you are able to become pregnant, you must be willing to use effective contraception.

However, some people won't be able to join. This includes if you have other significant medical conditions, certain infections (like Hepatitis B or HIV), or a weakened immune system from other causes. You also can't participate if you have severe heart or lung problems, or if you have other autoimmune diseases apart from the one being studied.

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 rheumatoid arthritis that's hard to treat or diffuse cutaneous systemic sclerosis?
Are you able to commit to 15 years of follow-up appointments?
Do you have generally good overall health (e.g., kidney, liver function) with no serious active infections or other major health problems?
If you can become pregnant, are you willing to use an effective method of birth control during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a procedure called leukapheresis. This is a bit like donating blood, but only some of your white blood cells are collected. These cells are then sent to a lab to create your personalised QEL-005 treatment.

Once QEL-005 is ready, you'll receive it through a drip into a vein (an IV infusion). You'll typically stay in the hospital overnight after this to be closely monitored. After leaving the hospital, you'll have regular check-ups at the clinic. These visits will include various tests like blood tests, scans, questionnaires about your symptoms and how you're feeling, and possibly small tissue samples (biopsies) to see how the treatment is working.

These detailed follow-up appointments will continue for a year after you receive QEL-005. Following this, there will be further long-term check-ups for a total of 15 years, which is standard for studies involving cell therapies. The study team will explain all the appointments and procedures in detail before you decide to join.

Potential risks and benefits

As an early-stage study, the main potential benefit of joining is contributing to medical research that could help others with similar conditions in the future. There's a chance you might experience an improvement in your symptoms or disease activity, but this is not guaranteed as the treatment is still experimental. Potential risks associated with QEL-005 and the procedures involved will be fully explained by the study team. These could include side effects from the treatment itself, risks from the cell collection (leukapheresis), or risks associated with the hospital visits and tests. It's very important to remember that participating in a clinical trial is always 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 (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham NHS Foundation Trust
Verified postcode
Birmingham, United Kingdom· Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Verified postcode
Leeds, United Kingdom· Recruiting
Guy's & St Thomas NHS Foundation Trust
Verified postcode
London, United Kingdom· Not yet recruiting
Royal Free London NHS Foundation Trust
Verified postcode
London, United Kingdom· Not yet recruiting
Newcastle Upon Tyne NHS Foundation Trust
Verified postcode
Newcastle, United Kingdom· Recruiting
University of Oxford - The Kennedy Institute
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What are autoimmune conditions?

Autoimmune conditions are when your body's defence system, called the immune system, mistakenly attacks your own healthy tissues instead of fighting off germs.

What is QEL-005?

QEL-005 is an experimental treatment made from your own white blood cells, which are specially modified in a lab to help calm an overactive immune system.

What is leukapheresis?

Leukapheresis is a procedure where some of your white blood cells are collected from your blood. It's similar to donating blood, but only specific cells are taken.

How long will I be involved in the study?

You'll have detailed check-ups for a year after receiving the treatment, followed by long-term monitoring for a total of 15 years, which is standard for cell therapies.

Will I receive QEL-005 if I join?

Yes, if you meet all the study requirements and are accepted, you will receive the experimental treatment QEL-005, as it's an 'open-label' study.

How to find out more

Quell Therapeutics Clinical Trials

contact@quell-tx.com +44(0)2070969012 Official trial record

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