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New treatment option for End-stage Liver Disease (ESLD)
Official title RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
ClinicalTrials.gov ID: NCT06823713
What this study is testing
What is RTX001?
RTX001 is an investigational medicine, being studied as a potential treatment for end-stage liver disease (esld).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Individuals eligible to participate in this study must meet the following criteria:
- 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.
You likely can't join 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...
- Known splenomegaly ≥16 cm.
See the full eligibility criteria
Who can join
- Individuals eligible to participate in this study must meet the following criteria:
- 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...
- 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...
- 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...
- 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:
What rules you out
- 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...
- 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.
- Transjugular intrahepatic portosystemic shunt (TIPSS).
- As judged by the Investigator, any evidence of intercurrent illness that is either life threatening or of clinical significance such that it might limit compliance with study procedures.
- Current or planned use of immunomodulators or immunosuppressive medication; note: low doses of corticosteroids up to 10 mg/kg/day prednisone or equivalent are permitted, or inhaled steroids to manage asthma.
- Received a gene or cell therapy at any time.
- Current or planned use of a live attenuated vaccines four weeks or fewer prior to enrolment (and for 3 months after the last administered dose of RTX001).
- Received any investigational product within the past 6 months, or five half-lives (whichever is longer) or participated in another investigational treatment study within 30 days prior to the screening visit.
- Participants with a known hypersensitivity to dimethyl sulfoxide (DMSO).
- Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- For female participants only - pregnant or breast-feeding or plans to become pregnant over the next year, or of childbearing potential and unwilling to comply with contraceptive requirements.
- Alcohol misuse in the period between identification of the participant as potentially suitable for this study to Screening (Visit 1), defined as alcohol intake greater than three units/day for females and four units/day...
- Intake of non-medically supervised drugs of abuse that are judged (by the Investigator) to be a high risk to the participants acute health or which makes the participant likely to be non-compliant with follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Córdoba, Spain
- Madrid, Spain
- Seville, Spain
- Bristol, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Nottingham, United Kingdom
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Córdoba, Spain; Madrid, Spain; Seville, Spain; Bristol, United Kingdom; Edinburgh, United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.