RTX001 Autologous Engineered Macrophages for Liver Cirrhosis

Recruiting now · Phase 1/Phase 2

Conditions studied: End-stage Liver Disease (ESLD), Cirrhosis, Liver, Cirrhosis, Decompensated, Liver Diseases, Fibrosis and Cirrhosis of Liver, Decompensated Liver Cirrhosis, Decompensated Cirrhosis, Steatotic Liver Disease

In brief

The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and anti-fibrotic effect, will be given to humans.

Key facts

Study ID: NCT06823713
Run by: Resolution Therapeutics Limited
People needed: 30
Starts: 2024-10-15
Expected to finish: 2028-11-29
Last updated by the study team: 2026-01-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female age ≥18-75 years.
Patient confirms willingness/ability to comply with all study procedures.
Diagnosis of liver cirrhosis based on at least one of:
Clinical and radiological features that correlate with a diagnosis of cirrhosis.
Transient elastography (Fibroscan) >15 kPa.
Previous liver biopsy confirming histological features of cirrhosis.
Aetiology of liver disease of steatotic liver disease including MASLD or Met-ALD or ALD
a. Participants with alcohol-related liver disease (ALD or Met-ALD) only if they are confirmed to not be drinking alcohol above Met-ALD limits defined in this protocol. (N.B. No more than 34% of the total treated participants in this protocol will be ALD [excludes Met-ALD]).
Hospitalised as an inpatient for a recent major hepatic decompensation event including ascites, hepatic encephalopathy, variceal bleed, HRS-AKI or SBP, this being the only hospitalisation for an hepatic decompensation event hospitalisation within the last 6 months, and where recent is defined as within 6 weeks of hospital discharge.
Outpatient: Medically refractory ascites (ONLY), that recurs (i.e., second therapeutic LVP) within a 6-month period. Medically refractory ascites is defined by the repeated (≥2) need for LVP (i.e., therapeutic, not diagnostic) at least once per 8 weeks despite best medical attempts to control the ascites by sodium restriction and diuretic treatment, as confirmed by the Investigator. Onset is defined as the date of the second therapeutic LVP.
Confirmatory PEth alcohol test <200 ng/ml
MELD score of 12-20 taken within two weeks of 'qualifying' decompensation event.
No known contradictions to filgrastim or leukapheresis procedure.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Willing and able to give signed informed consent, and if applicable assent.
Participants are excluded from the study if any of the following criteria apply:

You may not qualify if…

Liver cirrhosis due to:
any viral hepatitidies, or
autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.
Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.
Any current organ failure requiring more than outpatient supportive care, and not associated with the participant's qualifying hepatic decompensation event.
Known splenomegaly ≥16 cm.
Thrombocytopenia <50×109/L.
Presence or suspicion of any of the following co-morbidities:
History of liver transplantation or other organ transplant.
ACLF.
Sepsis (with positive microbial cultures) or as defined by the Principal Investigator, unless stable and is at least 4 weeks after having completed a full course of IV antibiotics.
Known human immunodeficiency virus.
Known syphilis.
Known human T-lymphotropic virus 1.
Pulmonary embolism.
Hepatocellular carcinoma, or any active malignant disease within the last five years, (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, benign polyps etc.).
Co-hepatic morbidities e.g., portal vein thrombosis.
Participants with hepatic hydrothorax are excluded unless it is a small hydrothorax, not clinically apparent, that is detected incidentally by radiologic evaluation that does not require clinical intervention.
Chronic renal impairment (on dialysis) or unresolved AKI.
Acute or chronic heart failure (New York Heart Association Grade III/IV).
Porto-pulmonary hypertension.
Severe chronic lung disease e.g., chronic obstructive pulmonary disease or interstitial lung disease where the forced expiratory volume in the first second (FEV1) is less than 50% and/or FEV1/forced vital capacity is less than 60%.
Hepatopulmonary syndrome.
Previous or current treatment with multiple infusions of albumin for therapeutic intent. [Use of albumin infusion at the time of large volume paracentesis for circulatory support is allowed.]
Significant untreated/unstable psychiatric disease.

Where it is running

Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
Hospital Universitario Reina Sofía — Córdoba, Spain (enrolling)
Hospital General Universitario Gregorio Marañon — Madrid, Spain (enrolling)
Hospital Universitario Ramón y Cajal — Madrid, Spain (enrolling)
Hospital Universitario La Paz — Madrid, Spain (enrolling)
Hospital Universitario Virgen del Rocío — Seville, Spain (enrolling)
Bristol Royal Infirmary — Bristol, United Kingdom (enrolling)
Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (enrolling)
Glasgow Royal Infirmary — Glasgow, United Kingdom (enrolling)
Royal Liverpool University Hospital — Liverpool, United Kingdom (enrolling)
King's College Hospital — London, United Kingdom (enrolling)
St George's Hospital — London, United Kingdom (enrolling)
St Mary's Hospital — London, United Kingdom (enrolling)
Nottingham University Hospital — Nottingham, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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