Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC

This study is testing a new therapy called NDV01 — delivered directly into the bladder — for patients with high-grade bladder cancer that has not spread into the muscle wall but has not responded well to the standard BCG treatment (a type of immune therapy given inside the bladder), and who are not candidates for or have chosen not to have bladder removal surgery. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with high-grade non-muscle-invasive bladder cancer confirmed by biopsy - Your cancer has not responded adequately to at least 5 out of 6 doses of BCG therapy - You are not eligible for or have decided against bladder removal surgery (cystectomy) - You have a life expectancy of more than 2 years - There is no evidence of cancer spread to the upper urinary tract **You may NOT be eligible if...** - Your cancer has spread into the bladder muscle or to other organs - You have cancer in the upper urinary tract (kidneys, ureters) or the prostate's urinary channels (unless confirmed free of disease) - You have a serious immune system condition or are on immunosuppressive drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.