We are doing this study to find out if an investigational drug called CG0070 (the study drug) is safe and effective for patients who have NMIBC that does not respond to BCG treatment.

Non-Muscular Invasive Bladder Cancer (NMIBC)

Adults ages 18+ who:

• Are diagnosed with NMIBC
• Have received BCG therapy but did not respond
• Are not pregnant
• Do not have heart, kidney, or gastrointestinal disease

For more information about who can join this study, please contact the study team at urologyresearch@duke.edu.

If you choose to join this study, you will receive the study drug directly into the bladder through a catheter every week for 6 weeks. You might receive more doses of the study drug after 6 weeks, which will depend on how you respond to the study regimen.

All participants will:

• Have blood and urine tests
• Have tumor samples taken
• Have physical exams
• Have images taken (CT scans)
• Have follow-up visits every 24-28 weeks after stopping the study drug

Participation in this study lasts up to 4 years.