Phase 2 Bladder Cancer 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:

• People aged 18 or older at the time of signing the consent form, of any gender
• People who have been diagnosed with a specific type of early-stage bladder cancer (non-muscle-invasive bladder cancer, including types known as Ta, T1, and/or CIS), confirmed by tissue testing
• People who are willing to undergo bladder examinations, urine tests, and tissue biopsies as required by the study
• People whose side effects from any previous cancer treatments (such as radiation or chemotherapy) have mostly resolved, with only mild effects remaining (exceptions may be discussed with the study team)
• People who are reasonably active and able to carry out daily activities, based on a standard health performance scale (score of 0–2)
• People with an expected survival of at least 24 weeks
• People whose blood counts, kidney function, liver function, and blood clotting results meet the study's required levels (the trial site will check these through standard blood tests)
• Women who could become pregnant must have a negative pregnancy test before starting the study and must agree to use effective contraception from signing the consent form until at least 6 months after the last dose
• Men who could father a child must agree to use effective contraception and not donate sperm from signing the consent form until at least 6 months after the last dose
• People who are willing and able to follow all trial requirements and who voluntarily sign the consent form

Who may not be able to join:

• People who have had, or currently have, bladder cancer that has grown into the muscle wall of the bladder or has spread to other parts of the body
• People who had a related cancer in the upper urinary tract or the urethra near the prostate within the past 24 months
• People who received chemotherapy, immunotherapy, targeted therapy, or other cancer treatments within the 4 weeks before starting the trial drug
• People who received radiation therapy within the 2 weeks before starting the trial drug
• People who are planning to receive any other cancer treatments during the study
• People with a known history of serious allergic reactions to certain components of the study drug or to similar biological substances (confirm with trial site)
• People who have had, or currently have, cancer that has spread to the brain, the lining of the brain, or the spinal cord
• People who currently have, or have previously had, another type of cancer (other than the bladder cancer being treated in this trial)
• People with a history of serious heart conditions, including severe heart rhythm problems, a heart attack or stroke within the past 6 months, heart procedures such as stenting within the past 6 months, significant heart valve problems, reduced heart pumping function below required levels, or poorly controlled high blood pressure
• People who have had severe immune-related side effects (Grade 3 or higher) from previous immunotherapy
• People who currently have active autoimmune diseases requiring ongoing treatment with immune-suppressing medications, or immune conditions that could return and require such treatment
• People who require immune-suppressing medications for any other condition
• People with an unexplained fever above 38.5°C at the time of screening or treatment (unless the fever is considered by the doctor to be caused by the tumour)
• People who are HIV-positive, have active hepatitis B with high viral levels, have active hepatitis C with detectable virus, or have other active infections requiring systemic treatment
• People who have previously had their spleen removed or have had an organ transplant
• People who have previously been treated with an oncolytic virus therapy (a type of cancer treatment using modified viruses)
• People who need to take oral or intravenous anti-herpes virus medications (such as acyclovir or similar drugs) during the study — topical use only may be acceptable (confirm with trial site)
• People with known psychiatric conditions that may affect their ability to follow the trial requirements, or who have a history of poor compliance with medical instructions
• People with a history of drug or alcohol misuse within the year before signing the consent form
• People who are currently pregnant or breastfeeding, or who plan to become pregnant or give birth during the trial
• People who have received a live vaccine within 4 weeks before starting the trial drug, or who plan to receive one during the study
• People who have recently undergone major surgery (confirm timing with trial site)
• People with any other medical condition, history, or circumstances that the investigating doctor believes would make participation unsafe or inappropriate

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