Phase 1 Liver Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old at the time of signing the consent form
• People diagnosed with liver cancer (hepatocellular carcinoma) according to recognised diagnosis guidelines
• People whose liver tumour tissue or spread (metastatic) tissue, tested within the past year, shows a certain level of a protein called GPC3 in at least 5% of tumour cells (during the dose-finding phase) or 10% of tumour cells (during the dose-expansion phase)
• People with a certain stage of liver cancer (BCLC stage B or C) that is either not suitable for local treatment, has come back after local treatment, or cannot be cured
• People whose liver cancer has stopped responding to standard treatments such as targeted therapy, immunotherapy, or chemotherapy, confirmed by imaging scans showing the disease has progressed
• People whose liver is still functioning at a level called Child-Pugh A or B7, with no signs of a condition called hepatic encephalopathy (confusion caused by liver disease)
• People with a performance score of 0 or 1 on the ECOG scale, meaning they are either fully active or have only minor limitations in daily activity
• People whose expected survival is at least 12 weeks
• People who have at least one tumour that can be measured on CT or MRI scan according to standard criteria (RECIST 1.1), with the tumour measuring at least 10 mm in its longest dimension, or lymph nodes measuring at least 15 mm across
• People who are able to have normal blood draws and a white blood cell collection procedure (called apheresis), with no medical reason preventing this
• People whose doctor determines that a lymphocyte-clearing treatment (a procedure to prepare the body before cell therapy) can safely be carried out
• Men and women who could potentially have children must agree to use effective contraception from signing the consent form until 2 years after receiving the study treatment; women of childbearing potential must have a negative blood pregnancy test at the time of screening

Who may not be able to join:

• People whose cancer has spread to the brain, the lining of the brain or spinal cord, or who have spinal cord compression
• People who have previously had a bone marrow or stem cell transplant from a donor, or an organ transplant
• People who have had a different type of cancer within the 3 years before joining the study, unless it was a fully treated and cured non-invasive (in situ) cancer or a fully treated and cured non-melanoma skin cancer
• People with hepatitis B markers in their blood (HBsAg or HBcAb positive) and a hepatitis B virus level above 500 IU/mL (people with hepatitis B markers who have been on antiviral treatment for at least 4 weeks before starting the study may still be considered — confirm with trial site)
• People who test positive for active hepatitis C virus, HIV, active syphilis, cytomegalovirus (CMV), or Epstein-Barr virus (EBV)
• People with a known allergy to any of the drugs used in this study, including albumin-bound paclitaxel, cyclophosphamide, or fludarabine
• People who have previously received any anti-cancer treatment that targets the GPC3 protein, including antibodies, antibody-drug combinations (ADCs), or cell therapies
• People whose liver tumour takes up more than 50% of the total liver, or who have cancer clots in the main portal vein or the large vein leading to the heart (inferior vena cava)
• People who received certain anti-cancer treatments too recently before the blood collection procedure, including chemotherapy, investigational drugs, antibody treatments, targeted therapies, local treatments or radiotherapy, or certain traditional Chinese medicines — specific timeframes apply for each type (confirm with trial site)
• People who had major surgery (other than a liver biopsy) within 28 days before the blood collection procedure, or who have major surgery planned during the study
• People who still have significant side effects from previous cancer treatments that have not improved to a mild or baseline level (with some exceptions such as hair loss or stable, well-managed conditions)
• People who had an active infection requiring antibiotic, antiviral, or antifungal treatment within the 4 weeks before the blood collection procedure
• People who had active tuberculosis within the past year (those with a history of tuberculosis more than 1 year ago may be considered if their doctor confirms there is no current active infection)
• People who have or have had a lung condition called interstitial lung disease or interstitial pneumonia, or who have extensive lung spread from cancer or other severe lung disease that their doctor believes would make treatment unsafe
• People who have an active or past autoimmune disease that could return, such as lupus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, or psoriasis
• People who needed high-dose steroid tablets or other immune-suppressing medicines within 2 weeks before the blood collection procedure or during the study (low-dose or locally applied steroids may be acceptable — confirm with trial site)
• People with significant heart or blood vessel disease (confirm with trial site for specific conditions)
• People with insufficient bone marrow function or inadequate organ function (confirm with trial site for specific thresholds)
• People who had a significant bleeding event requiring medical treatment within 28 days before the blood collection procedure, or who are assessed to be at high risk of gastrointestinal bleeding during the study
• People with poorly controlled fluid build-up around the lungs, heart, or in the abdomen, where the doctor considers this unsuitable for participation
• People who received a live vaccine within 28 days before the blood collection procedure, or who plan to receive one during the study
• People with a history of significant mental health disorders or substance misuse that would prevent safe participation in the study
• Women who are pregnant or breastfeeding
• People who the trial doctor considers unsuitable for any other reason that might affect their safety or ability to follow the study requirements

Important: Always verify eligibility with the trial site directly before applying.