Study of QEL-001 (CAR T regulatory cell therapy) to prevent liver transplant rejection in patients with HLA-A2 positive donor organ

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What is this study about?

This clinical study focuses on patients who have undergone liver transplantation and aims to prevent transplant rejection. The study evaluates a new treatment called QEL-001, which is made from the patient’s own modified immune cells (specifically T regulatory cells). These cells are specially engineered to recognize and target specific proteins found on the transplanted liver, potentially helping to prevent rejection of the organ.

The treatment involves collecting immune cells from the patient’s blood, modifying them in a laboratory to create QEL-001, and then returning them to the patient through intravenous injection. This is a type of personalized cell therapy where each treatment is specifically made for each individual patient using their own cells. The study will test a single dose of QEL-001 to determine if it is safe and well-tolerated by patients.

The study is designed for patients who received their liver transplant between 1 and 5 years ago from donors with specific tissue characteristics. The main purpose is to evaluate whether this treatment is safe and if it might allow patients to reduce or stop taking their regular anti-rejection medications. Patients will be monitored closely for any side effects and to see how well the treatment works in preventing rejection of the transplanted liver.

1 Initial treatment preparation

Your blood samples will be collected to create a personalized treatment called QEL-001, which contains modified immune cells

Medical tests will be performed to check your liver function, kidney function, and blood cell counts

Pregnancy test will be required for women who can become pregnant

2 Pre-treatment phase

You will receive medication called rATG to prepare your immune system for the treatment

3 Treatment administration

QEL-001 will be given as a single dose through an intravenous injection

The treatment contains your own modified immune cells designed to work with your liver transplant

4 Initial monitoring period

You will be monitored closely for the first 28 days after treatment

Regular checks will be performed to identify any possible side effects

Your liver function will be regularly tested

5 Long-term follow-up

Your progress will be monitored for one year after treatment

Regular blood tests will check your liver function

Your immunosuppression medication may be gradually reduced if your condition allows

Additional tests will be performed at weeks 14, 26, and 54 to check for specific markers in your blood

6 Study completion

The study will evaluate if you can safely reduce or stop your regular immunosuppression medication

Final assessments will determine the success of the treatment in preventing liver transplant rejection

Who Can Join the Study?

Must be between 18 and 75 years old at the time of signing consent
Must be able to understand and sign informed consent documents
Must be on stable anti-rejection medications for at least 12 weeks before starting the study
Must be HLA A2/A28 negative and have received a liver from an A2 positive donor (HLA refers to specific proteins on cells that help match organ donors and recipients)
Must have received liver transplant between 1 to 5 years ago with:
– No rejection episodes in the last 12 months (except early rejection in first 3 months after transplant)
– No previous rejections requiring special antibody treatment
Must have normal liver function tests:
– ALT (liver enzyme) below 60 U/L
– ALP (alkaline phosphatase) below 200 U/L or GGT below 100 U/L
Must have adequate kidney function (eGFR at least 40 mL/min/1.73 m2)
Must have adequate blood cell counts, including:
– Normal white blood cell counts
– Normal red blood cell (hemoglobin) levels
– Normal platelet counts
Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
Must agree to use effective birth control during the study and for 12 months after
Women who can become pregnant must have negative pregnancy test before starting treatment

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnant or breastfeeding women
History of allergic reactions to similar medications
Active infections or serious medical conditions that could interfere with the study
Previous organ transplantation other than liver
Use of other immunosuppressive medications not approved by the study team
Participation in another clinical trial within the past 30 days
Significant abnormalities in blood tests or organ function tests
History of substance abuse within the past 5 years
Mental conditions that could affect the ability to provide informed consent
Known HIV (Human Immunodeficiency Virus) infection
Active or chronic hepatitis B or C infection
Severe kidney dysfunction (as measured by specific blood tests)
Uncontrolled high blood pressure
History of cancer within the past 5 years (except for successfully treated skin cancer)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Cnhzghbzd Unovrpbavzggbb Sxkdakctp	Woluwe-Saint-Lambert	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.01.2023
Spain	Not recruiting	31.01.2023

Trial locations

Investigated drugs:

Autologous T Regulatory Cells Expressing An Hla-A2-Specific Chimeric Antigen Receptor

QEL-001 is an experimental cell therapy treatment that uses modified T regulatory cells from the patient’s own immune system (autologous cells). These cells are engineered in a laboratory to target specific proteins (HLA-A2) that are present on transplanted liver tissue. This therapy is designed to help prevent rejection in liver transplant patients by teaching the immune system to better accept the transplanted organ. The treatment is given as a single infusion of the modified cells back into the patient’s body.

Investigated diseases:

Liver transplant rejection

Liver transplant rejection – A condition where the recipient’s immune system recognizes the transplanted liver as foreign and attacks it. The immune system produces antibodies and activates immune cells that can damage the new liver tissue. This process can begin within days or weeks after transplantation, but it may also occur months or years later. The body’s immune response can cause inflammation and damage to the liver cells, affecting the organ’s ability to function properly. Rejection can develop gradually and may affect different parts of the liver tissue.

Trial ID:

2024-516193-30-01

Protocol code:

QEL-001-CLN-01

NCT ID:

NCT05234190

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of QEL-001 (CAR T regulatory cell therapy) to prevent liver transplant rejection in patients with HLA-A2 positive donor organ

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?