Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients

This study is testing a new treatment called QEL-001 for patients who have received a liver transplant. The main goal is to find out if QEL-001 is safe and how well it works to stop the body from rejecting the donated liver. QEL-001 is special because it's made from a patient's own cells, which are then specially changed to help the new liver be accepted by the body. The hope is that this treatment could allow patients to reduce or even stop taking their usual anti-rejection medicines, which can have many side effects. This is an early-stage study, checking the treatment in a small group of people to understand its effects better.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Quell Therapeutics Limited

Enrolment target

Start

21 Jan 2022

Estimated completion

01 Sep 2040

Rejection; Transplant, Liver Liver Failure Liver Diseases

What is this study about?

When someone receives a liver transplant, their body's immune system often sees the new liver as 'foreign' and tries to attack it. This is called rejection. To prevent this, patients usually need to take powerful medicines for the rest of their lives. These medicines are very important but can have unwanted side effects.

This study is looking at a new treatment called QEL-001. It's designed to help the body accept the donated liver more naturally, which could potentially mean patients wouldn't need as many anti-rejection medicines, or perhaps even none at all, over time. QEL-001 is unique because it's made directly from a patient's own cells. These cells are carefully collected and then prepared in a special way to teach the body's immune system not to reject the new liver. The study specifically involves patients whose new liver has a particular genetic marker (called HLA-A2) that is different from their own.

The main purpose of this early study is to check if QEL-001 is safe for people and to see how the body reacts to it. Researchers will also be looking for early signs of whether it helps prevent rejection, especially after a patient has started to reduce their other anti-rejection medications. This is an important step in developing new ways to help transplant patients live healthier lives.

Key takeaways

QEL-001 is an investigational treatment for liver transplant rejection.
It uses a patient's own specially modified immune cells.
The study aims to improve liver acceptance and potentially reduce anti-rejection medication.
It's an early-stage study focusing on safety and how well the body tolerates the treatment.
Participation involves strict eligibility criteria and close medical monitoring.

Who may be eligible?

The study is looking for adults aged 18 to 75 who have had a liver transplant between 12 months and 5 years ago. A key requirement is that your donated liver must have a specific genetic feature (called HLA-A2) that is different from your own body's genetic make-up for this marker. You also need to be in stable health and taking a steady dose of your usual anti-rejection medicines for at least three months.

There are also some reasons why you might not be able to join. For example, if you have other serious health problems like heart or lung disease, or certain infections like HIV or active tuberculosis. If you've had other organ transplants or a history of cancer in the last five years, you won't be able to take part. Also, if you have certain autoimmune diseases that needed strong treatment recently, or if you're already taking part in another research study, you wouldn't be eligible.

Before you can join, the study team will do some checks, including blood tests, to make sure you closely fit all the necessary criteria and that taking part would be safe for you. It's important to discuss your full medical history with your doctor if you're interested.

Quick self-check

Are you between 18 and 75 years old?
Did you have your liver transplant between 1 and 5 years ago?
Does your new liver have an HLA-A2 marker that your own body doesn't?
Are you currently on stable doses of your anti-rejection medicines?
Do you feel generally well and don't have other serious long-term health problems?

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, you'll first have screening tests to make sure you are suitable. Once confirmed, you would receive the QEL-001 treatment, which is made from your own cells. This involves a process to collect your cells, followed by a period where they are specially prepared, and then the treatment is given back to you.

After receiving QEL-001, you'll have regular hospital visits for check-ups, blood tests, and scans. The team will carefully monitor your health, how your liver is working, and how your body is responding to the treatment. They will also be looking at whether you can safely reduce your current anti-rejection medications over time. The study will involve ongoing follow-up for a specific period to monitor the long-term effects of QEL-001 and your general health, ensuring you are supported throughout the process.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. A potential benefit is that QEL-001 might help your body accept your new liver better, possibly reducing your need for daily anti-rejection medicines and their side effects. However, there's no guarantee this treatment will work for everyone, and it's also possible you could still experience rejection of your liver. There might be side effects from QEL-001 itself, or from the process of collecting and giving back your cells, which the study team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (10)

H. Saint Luc
Brussels, Belgium
Hopital Erasme
Brussels, Belgium
UZ Leuven
Leuven, Belgium
H. Clinic Barcelona
Barcelona, Spain
Hospital Reina Sofia
Córdoba, Spain
G. Gergorio Maranon
Madrid, Spain
Queen Elizabeth Hospital
Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom

Common questions

What is QEL-001?

QEL-001 is a new treatment being tested that uses specially modified cells from your own body to help prevent your immune system from rejecting your donated liver.

Why is this study important for liver transplant patients?

It could lead to new ways for liver transplant patients to reduce or even stop taking daily anti-rejection medications, which can have unpleasant side effects.

Who can take part in this study?

Adults aged 18-75 who had a liver transplant 1-5 years ago, and whose new liver has a specific genetic difference (HLA-A2 mismatch) from their own.

Will I have to stop my current anti-rejection medicines?

The study aims to see if you can safely reduce your anti-rejection medicines over time, but this would be done slowly and carefully under strict medical supervision.

What phase is this study in?

This is an early-stage study (Phase 1/2), meaning it's primarily looking at the safety of QEL-001 and how well people tolerate it, as well as early signs of how it works.