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 or older
• People who are able to understand the study and have signed a consent form
• People who have been diagnosed with high-grade non-muscle-invasive bladder cancer (a specific type of bladder cancer confirmed by laboratory testing, graded as grade 2 or grade 3)
• People whose life expectancy is at least 6 months
• People who are reasonably physically active and able to care for themselves, with only limited help needed for daily activities (confirm with trial site)
• People whose blood, liver, and kidney test results meet certain minimum levels (confirm with trial site for specific values)
• People who are able to tolerate a urinary catheter
• Women who could become pregnant, and their partners, who are willing to use effective non-medication-based contraception from the time of signing the consent form until at least 6 months after the last treatment

Who may not be able to join:

• People with a known allergy to RAG-01 or similar products
• People who have received any anti-cancer treatment other than TURBT (a surgical procedure to remove bladder tumours) within approximately 21 days or 5 half-lives of the study drug (whichever is shorter) before signing the consent form
• People whose scans or imaging show that cancer has spread outside the bladder, including to the ureter or urethra
• People who have had another cancer within the past 3 years, except for certain well-treated cancers of the cervix, skin, or prostate (confirm with trial site for specific details)
• People who have certain ongoing or uncontrolled health conditions that have not sufficiently resolved, including uncontrolled infections (such as pneumonia, hepatitis B, or hepatitis C), breathing difficulties, kidney injury or inflammation, urinary incontinence, frequent urination, or urinary blockage (other than that caused by an enlarged prostate)
• People who are unable to hold their urine for at least 90 minutes for any reason
• People with moderate to severe heart failure (classified as New York Heart Association grade 3 or 4)
• People with ongoing unresolved heart-related conditions such as heart attack, unstable chest pain, congestive heart failure, or irregular heartbeat
• People with a specific heart rhythm measurement (QTc) above 470 milliseconds on an ECG
• People who have had a stroke or other brain blood vessel event that has not sufficiently resolved
• People who are HIV positive, or who have active hepatitis B or hepatitis C infection
• People who are pregnant or breastfeeding during the treatment period
• People with a history of central nervous system or psychiatric conditions such as epilepsy or dementia
• People with other serious ongoing illnesses that could affect their ability to participate in the study, such as uncontrolled diabetes, certain digestive conditions, or kidney disease
• People whom the trial investigators judge to be at unnecessary risk for any other reason

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