Actively Recruiting
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
Led by Resolution Therapeutics Limited · Updated on 2026-01-28
30
Participants Needed
14
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Willing and able to follow all study procedures
- Diagnosis of liver cirrhosis confirmed by clinical/radiological features, Fibroscan >15 kPa, or liver biopsy
- Liver disease due to steatotic liver disease including MASLD, Met-ALD, or ALD (with controlled alcohol intake)
- Hospitalized recently for a major hepatic decompensation event within 6 weeks of discharge or outpatient with medically refractory ascites recurring within 6 months
- Confirmatory PEth alcohol test below 200 ng/ml
- MELD score between 12 and 20 within two weeks of qualifying decompensation event
- No known contraindications to filgrastim or leukapheresis
- Use of contraception consistent with local regulations
- Able and willing to provide informed consent or assent
You will not qualify if you...
- Liver cirrhosis caused by viral hepatitis or autoimmune/cholestatic diseases
- Acute liver disease without underlying cirrhosis
- Current organ failure requiring more than outpatient care unrelated to qualifying event
- Known splenomegaly ≥16 cm
- Platelet count below 50 x10⁹/L
- History of organ transplant, ACLF, sepsis within last 4 weeks, HIV, syphilis, HTLV-1, pulmonary embolism
- Hepatocellular carcinoma or active cancer within 5 years (except certain non-serious cancers)
- Co-hepatic conditions like portal vein thrombosis
- Clinically significant hepatic hydrothorax requiring treatment
- Chronic renal impairment on dialysis or unresolved acute kidney injury
- Severe heart failure (NYHA III/IV) or porto-pulmonary hypertension
- Severe chronic lung disease with FEV1 <50% or FEV1/FVC <60%
- Hepatopulmonary syndrome
- Previous or current multiple albumin infusions for therapy (except during paracentesis)
- Untreated or unstable psychiatric disease
- Transjugular intrahepatic portosystemic shunt (TIPSS)
- Intercurrent illness limiting study compliance
- Use of immunomodulators or immunosuppressants (low-dose corticosteroids or inhaled steroids allowed)
- Prior gene or cell therapy
- Use of live vaccines within 4 weeks before enrollment or within 3 months after RTX001
- Participation in other investigational studies within past 6 months or 30 days before screening
- Known allergy to dimethyl sulfoxide (DMSO)
- Unlikely to comply with study procedures
- Pregnant, breastfeeding, or unwilling to use contraception if of childbearing potential
- Alcohol misuse above defined limits or binge drinking before screening
- Use of non-medically supervised drugs posing high health risk or compliance issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
2
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Actively Recruiting
3
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
4
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
5
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
6
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
7
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Actively Recruiting
8
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
9
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Actively Recruiting
10
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8YE
Actively Recruiting
11
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
12
St George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
13
St Mary's Hospital
London, United Kingdom, W2 1NY
Actively Recruiting
14
Nottingham University Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
Research Team
R
Resolution Therapeutics Clinical Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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