Windsor Gardens

Researchers are evaluating the safety and effectiveness of EG-70, a new gene therapy designed to trigger a local immune response in the bladder, for patients with non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS). This trial includes patients who did not respond to BCG therapy as well as those who are BCG-nafve or received incomplete BCG treatment. The study consists of two phases: Phase 1 focuses on safely determining the recommended dose, and Phase 2 assesses how well the treatment works. In Phase 1, patients receive up to four cycles of EG-70 administered directly into the bladder via catheter, with each cycle lasting about 12 weeks and involving either 2 or 4 doses per cycle. In Phase 2, patients receive up to four 12-week treatment cycles at the recommended dose, followed by maintenance treatment cycles if they achieve a complete response. Maintenance cycles involve two doses per 12-week period, and patients may receive up to eight maintenance cycles total. The therapy is delivered as a 50 mL bladder instillation with a targeted retention time of 60 minutes. Participants will have regular assessments including exams, urine cytology, and biopsies to monitor tumor response and safety. Researchers will track adverse events over approximately 2 to 3 years and measure the percentage of patients achieving a complete response at 48 weeks. Safety evaluations will follow standard criteria, and follow-up will continue for those with ongoing treatment benefits. Total participation may last several years, depending on individual response and treatment cycles.