Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Inclusion Criteria:

• Male or female participants 18 years of age or older at the time of signing informedconsent

• Participants who have voluntarily given written informed consent after the nature ofthe study has been explained according to applicable requirements prior to studyentry

• Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) withactive disease

• Participants who are BCG naive, or participants who are BCG exposed and have notreceived intravesical BCG for at least 24 months prior to the most recent CISdiagnosis (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.

Exclusion Criteria:

• Penicillin allergy (participants with a questionable history of allergy topenicillin will undergo penicillin blood allergy testing via central laboratory

• Central confirmed variant histology

• Concomitant prostatic or upper tract urothelial involvement per Investigator'sassessment

• Nodal and metastatic disease are excluded if they existed at any time (whetherpresent or in the past)

• Any history of ≥ T2 bladder cancer that existed at any point in time in theparticipant's history

For more information on eligibility criteria, please contact the Sponsor