Phase 1b2 Study of OH2 Oncolytic Virus Therapy as Additional Treatment After Tumor Removal in Non-Muscle-Invasive Bladder Cancer That Did Not Respond to First-Line Preventive Instillation Therapy

What this Trial Is About

Researchers are studying the safety and effectiveness of OH2, an oncolytic virus based on herpes simplex virus type 2, for treating non-muscle-invasive bladder cancer that has not responded to first-line preventive bladder treatments. This phase 1b2 clinical trial aims to explore OH2 as an additional therapy to help control the cancer and boost the immune systems anti-tumor response. The study involves a single group of participants receiving OH2 through bladder instillations. The treatment has two stages an induction period where OH2 is given every two weeks, followed by a maintenance period with monthly treatments. Two different virus doses are tested, starting with the lower dose before moving to the higher one. The virus is delivered directly into the bladder to target tumor cells. Participants will be monitored regularly for side effects and cancer recurrence using urine tests, bladder examinations, and ultrasound imaging of the urinary system. Researchers will assess safety, relapse-free survival at 6 and 12 months, and disease progression over a year. The study includes laboratory tests to check blood counts and organ function, and participants will be followed for at least one year after treatment.

OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer