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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 2

    Pre-treatment phase

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

  3. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

15 criteria

  • 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)
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Investigated drugs

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.

What is already known about the treatment

QEL-001 - An innovative autologous CAR T regulatory cell therapy designed specifically for transplant patients, administered as a single-dose treatment through intravenous infusion. This investigational medication represents a personalized cell therapy approach that targets HLA-A2 in liver transplant recipients, aiming to prevent organ rejection by modifying the patient's own regulatory T cells. The medication works by engineering the patient's immune cells to recognize specific markers on the transplanted liver tissue, potentially creating a more targeted and effective approach to preventing transplant rejection compared to conventional immunosuppressive medications. Currently in Phase I/II clinical trials, this therapy belongs to the class of cell-based immunotherapies and represents an emerging approach in transplant medicine.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-516193-30-01Protocol codeQEL-001-CLN-01Estimated enrolment32 patientsSponsorQuell Therapeutics Limited

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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