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Safety and efficacy study of RTX001 autologous macrophage therapy in patients with decompensated liver cirrhosis

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial investigates a new treatment for patients with liver cirrhosis who have experienced complications of their disease. The study focuses on patients whose liver condition has worsened, leading to complications such as fluid buildup in the abdomen, mental confusion, or bleeding. The main treatment being tested is called RTX001, which consists of specially modified white blood cells (macrophages) that are taken from the patient's own body and then given back through an infusion into the vein. During the treatment, patients will also receive filgrastim (Neupogen), a medication that helps produce more white blood cells.

The purpose of this research is to determine if RTX001 is safe to use and how well patients tolerate the treatment. The study will involve collecting cells from the patient's blood through a procedure called leukapheresis, processing these cells to create RTX001, and then giving the processed cells back to the patient through an intravenous infusion. Researchers will monitor patients for any side effects and track how their liver condition changes after receiving the treatment.

This is an early-phase study that will help researchers understand how this new cell therapy might work for patients with severe liver disease. The treatment approach is considered experimental, as it uses modified cells from the patient's own immune system to potentially help improve liver function. Throughout the study, patients will have regular check-ups to monitor their health and assess how they respond to the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and qualification

    Your eligibility will be evaluated based on specific medical criteria, including confirmation of liver cirrhosis

    A blood test called MELD score (which measures liver function) must be between 12-20

    An alcohol test (PEth) must show levels below 200 ng/ml

  2. Step 2

    Medical history verification

    Confirmation of recent hospitalization for liver-related complications within the past 6 weeks

    Or verification of requiring at least two fluid drainage procedures (therapeutic LVP) within 6 months for persistent stomach fluid buildup (ascites)

  3. Step 3

    Treatment preparation

    You will receive filgrastim (Neupogen), a medication given through injection

    A procedure called leukapheresis will be performed to collect specific cells from your blood

  4. Step 4

    Main treatment administration

    RTX001 treatment will be given through an intravenous infusion

    Medical staff will monitor for any reactions during the infusion

  5. Step 5

    Follow-up monitoring

    Regular assessments to monitor liver function and overall health

    Tracking of any liver-related complications

    Monitoring of MELD score changes throughout the study period

    The study will continue until August 2028

Who can join the trial?

11 criteria

  • Age between 18 and 75 years at the time of signing the consent form
  • Must be able to follow all study procedures
  • Must have liver cirrhosis confirmed by at least one of: - Clinical and imaging tests showing cirrhosis - Liver stiffness measurement (Fibroscan) above 15 kPa - Previous liver biopsy showing cirrhosis
  • Must have liver disease caused by fatty liver conditions, including: - Metabolic dysfunction-associated steatotic liver disease (MASLD) - Metabolic dysfunction-associated alcohol-related liver disease (Met-ALD) - Alcohol-related liver disease (ALD) with limited alcohol consumption
  • Must have been hospitalized within the last 6 weeks for complications of liver disease such as: - Fluid in the abdomen (ascites) - Mental confusion due to liver disease (hepatic encephalopathy) - Bleeding from enlarged veins (variceal bleeding) - Kidney problems related to liver disease (HRS-AKI) - Bacterial infection in abdominal fluid (SBP)
  • For outpatients: Must have severe ascites requiring repeated drainage procedures despite medical treatment
  • Must have an alcohol test (PEth) result below 200 ng/ml
  • Must have a MELD score (measure of liver disease severity) between 12-20
  • Must not have any conditions that prevent the use of filgrastim or cell collection procedure
  • Must use appropriate contraception methods according to local regulations
  • Must be willing to provide informed consent and follow study requirements

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding women
  • Active hepatitis B (viral liver infection) or hepatitis C infection
  • History of hepatocellular carcinoma (liver cancer)
  • Severe portal hypertension (high blood pressure in liver blood vessels)
  • Recent gastrointestinal bleeding within past 6 months
  • Current alcohol or substance abuse
  • Severe kidney dysfunction
  • Uncontrolled heart disease
  • Active infection requiring treatment
  • Participation in another clinical trial within past 30 days
  • Known allergic reactions to similar medications
  • Inability to provide informed consent
  • Severe psychiatric conditions that could interfere with study compliance
  • History of organ transplantation
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Investigated drugs

RTX001 is an experimental therapy that uses the patient's own macrophages (a type of immune cell). This treatment involves collecting the patient's immune cells, modifying them outside the body, and then returning them to the patient. It is being studied as a potential treatment for patients who have liver cirrhosis with complications. The therapy aims to help patients whose liver function has deteriorated due to advanced liver disease.

What is already known about the treatment

RTX001 - An experimental autologous macrophage therapy administered through cell infusion, currently being investigated in clinical trials for the treatment of liver cirrhosis with hepatic decompensation. This innovative cellular therapy involves using the patient's own macrophages (a type of immune cell) that are processed and modified before being reintroduced to the patient's body. The treatment aims to improve liver function in patients with decompensated cirrhosis by potentially reducing inflammation and promoting tissue repair, though its exact molecular mechanism is still being studied in clinical trials. RTX001 represents a new class of cell-based therapeutic approaches and is currently undergoing Phase 1/2 clinical trials to evaluate its safety, tolerability, and efficacy in patients with advanced liver disease.

Investigated diseases

Liver Cirrhosis - A chronic liver disease where healthy liver tissue is gradually replaced by scar tissue, disrupting normal liver function. The scarring process occurs slowly over time as a result of various factors that damage liver cells. As cirrhosis progresses, the liver becomes increasingly nodular and hardened, which interferes with blood flow through the organ. This condition can lead to portal hypertension, where blood pressure increases in the portal vein system. The disease affects the liver's ability to process nutrients, filter toxins, and produce proteins essential for blood clotting. When cirrhosis develops, the liver loses its ability to repair and regenerate damaged tissue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516288-10-00Protocol codeRTX001-002Estimated enrolment24 patientsSponsorResolution Therapeutics Limited

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