• Meet the following histopathologic requirements for urothelial carcinoma:

‣ For Cohorts 1b, 4a-c:

• histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months).

• For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to

• AUA risk classification guidelines) is required, specifically:

⁃ Multifocal LG Ta; OR

⁃ Solitary LG Ta \>3 cm; OR

⁃ Low-grade Ta with prior recurrence(s) within 1 year.

• For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:

⁃ Ta HG papillary disease with or without CIS; OR

⁃ T1 papillary disease with or without CIS

⁃ Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)

⁃ BCG-refractory participants are excluded. BCG-refractory is defined by the following:

• Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR

∙ HG T1 disease at first evaluation (3 months) after BCG, OR

∙ Persistent CIS that remains despite a second BCG course, OR

∙ Disease progression in stage or grade during BCG therapy, including maintenance

• Have no evidence of current or prior metastatic urothelial carcinoma

• Adequate bone marrow, renal, and hepatic function