Phase 1 Type 1 Diabetes Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older.
• People who have been diagnosed with biliary tract cancer (a cancer affecting the bile ducts or gallbladder), confirmed through a laboratory test of cancer tissue, and who have previously been treated with a specific combination of chemotherapy and immunotherapy drugs (gemcitabine, cisplatin, and an anti-PD-1/PD-L1 immunotherapy).
• People whose cancer can be seen on medical imaging, who are willing to have a small tissue sample (biopsy) taken from an accessible tumour at the start of the study and again during treatment.
• People who have enough stored tumour tissue available for specialised genetic and immune testing.
• People whose cancer has at least one specific genetic change that is targeted by the vaccine being studied in this trial.
• People who are fairly physically active and able to carry out daily activities with little or no limitation (confirm with trial site for exact definition).
• People who weigh more than 30 kg.
• People whose liver, kidneys, bone marrow, and other organs are functioning well enough, as measured by specific blood tests set out by the study.
• People with a hepatitis B or hepatitis C infection, provided the infection is well controlled before joining the trial.
• Women who could become pregnant must have a negative pregnancy test before joining.
• Both women and men must agree to use an acceptable form of contraception throughout the study.
• People with a life expectancy of at least 12 weeks.
• People who are able to understand the study and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

• People who have taken part in another clinical trial involving an experimental treatment within the last 2 weeks.
• People who are expected to need any other cancer treatment (systemic or localised) during the study.
• People who have received high-dose steroid medications (above the equivalent of 10 mg per day of prednisone) within the 2 weeks before starting the study treatment — though certain low-dose or localised steroid uses may be exceptions (confirm with trial site).
• People who have received palliative or additional radiation therapy, or a specific type of brain radiation treatment (gamma knife radiosurgery), within the 2 weeks before starting treatment.
• People who have received chemotherapy or immunotherapy drugs targeting PD-1/PD-L1 within the 2 weeks before starting treatment.
• People who have received any experimental cancer drug or device, a live-virus vaccine (for non-cancer conditions), allergy desensitisation treatment, growth-stimulating injections (such as G-CSF or erythropoietin), or undergone major surgery within the 4 weeks before starting treatment.
• People who still have unresolved side effects (rated moderate or worse) from previous cancer treatments, with some exceptions such as hair loss or skin pigment changes.
• People with moderate or severe nerve damage (neuropathy) — these cases will be considered individually by the study doctor.
• People who had any side effects from prior immunotherapy that have not fully resolved or returned to their previous baseline level.
• People who experienced a serious (Grade 3 or higher) immune-related reaction, or any immune-related nerve or eye problem of any severity, during previous immunotherapy treatment.
• People who have previously been treated with anti-PD-1 or anti-PD-L1 immunotherapy drugs (confirm with trial site, as this appears to overlap with the inclusion criteria and should be clarified directly).
• People who have had a severe allergic reaction to monoclonal antibodies or related compounds, or to any ingredients used in the study treatment.
• People with a history of cancer spreading to the membranes surrounding the brain or spinal cord (leptomeningeal carcinomatosis).
• People with a known history or current evidence of cancer that has spread to the brain.
• People with an active autoimmune disease, or one that has needed systemic medical treatment in the last 5 years.
• People with a known history of a lung condition called interstitial lung disease, or inflammation of the lungs (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People whose blood oxygen level, measured by a fingertip device, is below 92% while breathing normal room air.
• People who need to use supplemental oxygen at home.
• People with a known history of HIV/AIDS.
• People who have both hepatitis B and hepatitis C infections at the same time, or both hepatitis B and hepatitis delta virus infections at the same time.
• People with serious uncontrolled health conditions, such as uncontrolled infections, heart failure, unstable chest pain, irregular heart rhythm, or significant mental health or social circumstances that would make it difficult to follow the study requirements.
• People who have been diagnosed with another cancer or a blood disorder in the past 5 years that required systemic treatment, or that is expected to need active treatment during the study period.
• People with a known immune deficiency condition.
• People who have received a transplanted organ or tissue from another person (including corneal transplants), or who have previously had a bone marrow or stem cell transplant.
• People whom the study doctor determines should not participate for any other valid medical, psychological, or social reason.
• People who currently use, or have used within the past year, illicit drugs or have had a significant problem with alcohol or substance use.
• People who are unwilling or unable to follow the study schedule for any reason.
• People who are pregnant or currently breastfeeding.
• Women who could become pregnant, or men whose female partners could become pregnant, who are not willing to use contraception.
• People who have had fluid build-up in the abdomen requiring a drainage procedure in the last 4 weeks.
• People with a history of a bowel blockage caused by cancer.

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