Male or female participants 18 years of age or older at the time of signing informed consent
Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.
You may not be if
Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
Central confirmed variant histology
Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history
For more information on eligibility criteria, please contact the Sponsor
Clareo Health | Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
