A single-arm, open-label, multi-centre, phase I/II first-in-human study evaluating the safety and clinical activity of QEL-005, an autologous CAR T-regulatory cell therapy treatment targeting CD19, in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA).
This study is looking into a new treatment called QEL-005. It's a special type of cell therapy made from a person's own immune cells, designed to help calm an overactive immune system. The trial is for adults with a severe skin condition called diffuse cutaneous systemic sclerosis (dcSSc) or a specific type of hard-to-treat rheumatoid arthritis (D2TRA). This is the very first time this treatment is being given to people, so the main goals are to check how safe it is and if it shows any signs of helping these conditions. Researchers will carefully watch for any side effects and see how patients respond to different doses of the treatment.
At a glance
What is this study about?
This research study is about a new way to treat two difficult health conditions: diffuse cutaneous systemic sclerosis (dcSSc) and a specific type of hard-to-treat rheumatoid arthritis. Both of these conditions involve the body's immune system mistakenly attacking healthy tissues. The new treatment being tested is called QEL-005. It's a type of 'cell therapy,' which means it uses special cells to try and correct what's going wrong in the body.
Think of it like this: your immune system has different types of cells, some that fight off germs and others that help keep the immune system in check. In conditions like dcSSc and rheumatoid arthritis, the immune system might not be working quite right. QEL-005 involves taking some of a person's own immune cells, modifying them in the lab, and then putting them back into the body. The goal of these specially modified cells is to help calm down the overactive parts of the immune system.
This study is the very first time this particular treatment is being given to people, known as a 'first-in-human' study. This means the researchers will be extra careful, starting with small doses and closely watching how people react. They want to find out if the treatment is safe and if it shows any promise in helping people manage their symptoms and improve their health. This research is important because it could lead to new treatment options for people who haven't found enough relief from current medicines.
Key takeaways
- Tests a new cell therapy (QEL-005) for dcSSc and D2TRA.
- It's the first time this treatment is being used in humans.
- Mainly focuses on safety and checking for side effects.
- Also looking for early signs of the treatment working.
- For adults aged 18+ with specific forms of these conditions.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
This study is for adults generally aged 18 years and older. Both men and women can participate. To be considered for this study, you must have either diffuse cutaneous systemic sclerosis (dcSSc) or a type of rheumatoid arthritis that has been difficult to treat with other medications.
The research team will have specific medical criteria to decide if this study is suitable for you. This often includes things like your overall health, how long you've had your condition, and what other treatments you've tried. They will also need to make sure that the treatment itself isn't likely to cause problems with any existing health issues you might have.
It's important to remember that not everyone with these conditions will be able to join the study. The researchers need to select participants very carefully to ensure their safety and to get clear answers about the new treatment.
- Are you 18 years old or older?
- Do you have diffuse cutaneous systemic sclerosis (dcSSc)?
- Or do you have a type of rheumatoid arthritis that has been difficult to treat?
- Are you willing to attend regular clinic appointments and have medical tests?
- Are you able to understand and be comfortable with the study requirements?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the new treatment called QEL-005. Before and after receiving the treatment, you will have regular visits to the clinic. These visits will involve various checks, such as blood tests, heart checks (like an ECG), and monitoring of your blood pressure and other vital signs. This is to make sure you are safe and to see how your body is responding to the treatment.
The study will have different stages. In the first stage, a small number of participants will receive very carefully controlled doses of QEL-005 so researchers can understand its safety and how much treatment is needed. Later stages will involve more people receiving the treatment. You will also have follow-up appointments over a period of time to track your health and any effects of the treatment. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (2)
- —Spain
- —Germany
Common questions
What is 'cell therapy'?
Cell therapy uses special cells to help treat diseases. In this study, some of your own immune cells are collected, changed in a lab, and then given back to you to help your immune system.
What are the conditions being studied?
This study is for people with diffuse cutaneous systemic sclerosis (dcSSc) – a severe skin condition – or a type of rheumatoid arthritis that is very difficult to treat.
Is this a new treatment?
Yes, this is the very first time this treatment, QEL-005, is being given to people. This means doctors will be extra careful in checking its safety.
What does 'Phase I/II' mean?
These are early stages of clinical research. Phase I mainly checks if a treatment is safe, and Phase II checks safety further and also looks for early signs that the treatment is working.
Will I get better if I join?
While the aim is to find effective treatments, there's no guarantee that you will personally benefit. The main goal of this early study is to learn if the treatment is safe and shows promise.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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