Kapitanivka

Researchers are evaluating the safety and effectiveness of TARA-002, given directly into the bladder, in adults aged 18 years or older with high-grade non-muscle invasive bladder cancer, including carcinoma in situ (CIS) with or without Ta/T1. This Phase 2, open-label study focuses on participants who have active disease confirmed at their last tumor evaluation, enrolling them into two groups based on their prior exposure to BCG treatment. All participants receive six weekly doses of TARA-002 at a dose established in a previous Phase 1 study during the first treatment period. Those eligible for reinduction receive six more weekly doses in the second treatment period. Participants who achieve a complete response after the first treatment receive three additional weekly doses as maintenance during the second period. A third treatment period provides all eligible participants with three weekly doses at months 6, 9, 12, 15, and 18. Following treatment, participants enter a follow-up phase lasting from month 21 to month 60. During the study, researchers assess the occurrence of a high-grade complete response at any time from month 3 to month 60, including subgroup analyses for certain cohorts. Participants undergo pathology reviews to confirm response. The study monitors safety and efficacy throughout treatment and long-term follow-up, with evaluations designed to capture the duration and quality of the treatment response over several years.