CLINICAL TRIAL / NCT05483868

Inclusion Criteria: 1. Confirmed diagnosis urothelial carcinoma of the bladder (Recurrence of prior NMIBC biopsy or pathology must be obtained within 12 months prior to enrollment. First time NMIBC biopsy within 6 months of screening. MIBC allowed if demonstrated pathologically) 2. Have no evidence of metastatic disease 3. Adequate bone marrow, renal, and hepatic function Exclusion Criteria: 1. Any additional malignancy that requires active treatment. Exceptions include: 1. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year. 2. In situ cervical cancer treated and with at least 1 year without recurrence. 3. Any other subject felt appropriate by the Investigator upon discussion with trial's Medical Monitor. 2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial. 3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents. 4. Chronic active hepatitis B or C and HIV.