Phase 1 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 to 75 years at the time of consenting to join the trial
• People with a laboratory-confirmed diagnosis of urothelial carcinoma (a type of cancer affecting the bladder, ureter, kidney pelvis, or urethra) that cannot be surgically removed or has spread to other parts of the body
• People whose cancer has continued to grow after standard treatments, who could not tolerate standard treatments, or who were not suitable for standard treatments — including platinum-based chemotherapy and certain immunotherapy drugs; previous treatment with enfortumab vedotin or HER2-targeted therapy is also permitted
• People who have at least one tumour that can be measured on scans, according to standard measurement guidelines
• People whose tumour tissue, reviewed centrally, shows the presence of a protein called Nectin-4 and has had HER2 status tested; at least one of these two targets must be detected in the tumour
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People with adequately functioning bone marrow, liver, kidneys, and blood clotting system
• People with a life expectancy of at least 12 weeks
• Women who could become pregnant must have a negative pregnancy test before joining and must agree to use highly effective contraception during and after treatment, as defined by the trial protocol
• People who are able to understand the trial information and sign a consent form

Who may not be able to join:

• People with cancer that has spread to the brain or the lining around the brain or spinal cord that is currently active or has not been treated; previously treated cases may be considered if the condition is stable and no longer requiring increasing doses of steroids
• People who have previously received a bone marrow or stem cell transplant from a donor, a solid organ transplant, or who currently have graft-versus-host disease (a complication from transplants)
• People with a significant autoimmune disease that has required whole-body immune-suppressing treatment within a specified recent time period
• People with an uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV, blood poisoning (sepsis), or active tuberculosis
• People with serious heart conditions, including active heart muscle inflammation, unstable chest pain, a recent heart attack, uncontrolled irregular heartbeat, or a meaningfully reduced heart pumping function
• People with serious lung conditions, such as uncontrolled lung scarring or breathing difficulties requiring ongoing oxygen
• People who have recently used steroid medications or other immune-suppressing drugs above the levels permitted by the trial protocol
• People with a history of severe allergic reactions to fludarabine, cyclophosphamide, or ingredients used in the cell-based treatment product
• People who are pregnant or breastfeeding
• People who have another active cancer that requires systemic (whole-body) treatment or that could affect the trial's assessments, except for certain low-risk cancers that the protocol specifically permits

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