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:

• Your cancer has been confirmed through a tissue or cell sample (biopsy or lab test).
• Your cancer has spread to other parts of the body or cannot be removed, and it cannot be cured with current treatments; any previously treated tumors must show signs of growth to be counted.
• Your tumor has a specific protein called "ESO" (also known as cancer-testis antigen), confirmed through a tissue sample — either one already stored or a new biopsy taken for this study.
• You have already tried at least one or two standard treatments for your cancer that did not work, were too difficult to tolerate, or your cancer came back — or your cancer returned within 6 months of finishing a type of chemotherapy/treatment after surgery.
• If you have cancer that has spread to the brain, you have 3 or fewer small spots (less than 1 cm each), they are not causing symptoms, and any treated spots have been stable for at least 1 month.
• It has been more than 4 weeks since your last cancer treatment, and any side effects from that treatment have mostly resolved (Grade 1 or milder), except things like hair loss or skin colour changes.
• You are between 18 and 70 years old.
• You are able to understand and willing to sign a consent form.
• You are generally able to carry out daily activities (confirm with trial site what performance level is required).
• You have a specific genetic marker on your immune cells called HLA-A*0201 or HLA-A*0206 (a blood test can confirm this).
• You are willing to use birth control from the time you join the study until 4 months after treatment ends.
• If you could become pregnant, you have a negative pregnancy test.
• Blood tests show you are negative for HIV, hepatitis B, and hepatitis C (if a hepatitis C antibody test is positive, a further test must confirm the virus is not active).
• Your blood counts meet certain minimum levels: enough white blood cells, infection-fighting cells, platelets, and red blood cells (specific numbers will be checked by the trial team).
• Your liver, kidney, and blood-clotting functions are within acceptable ranges based on blood tests (specific values will be checked by the trial team).

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People who have a condition that severely weakens their immune system from birth (such as Severe Combined Immunodeficiency).
• People who have an active serious infection, a blood-clotting disorder, or another serious uncontrolled medical condition.
• People currently taking steroid medications (above a low daily dose) or any other medicines that suppress the immune system within the 7 days before starting the study treatment.
• People who have had a severe allergic reaction to certain medications used in this study (cyclophosphamide, fludarabine, or aldesleukin).
• People who have had a stroke, unstable chest pain (angina), a heart attack, or a serious heart rhythm problem requiring treatment within the past 3 months.
• People who cannot maintain normal blood oxygen levels while breathing regular room air.
• People who have had a blood clot in a vein and meet certain conditions — such as being on blood-thinning medication for less than 1 month, having had significant bleeding in the last 30 days, or still experiencing symptoms from the clot (confirm details with trial site).
• People who have had another type of cancer in the last 3 years — with some exceptions for very early-stage cancers that have been successfully treated (confirm with trial site).
• People whose heart pumping function is too low (below a certain level shown on a heart scan).
• People with reduced lung function (based on a breathing test), particularly long-term smokers or those with breathing problems (confirm with trial site).
• People currently taking part in another clinical trial with an experimental treatment.
• People whose cancer has spread to the lining around the brain, or who have more or larger brain tumours than those described in the inclusion criteria above.
• People who have received a live vaccine (such as for measles, mumps, chickenpox, or yellow fever) within 30 days before starting the study treatment. Note: most standard flu injections are allowed, but the nasal spray flu vaccine is not.

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