Phase 1ab Study of OPB-101, a Modified CAR T Cell Therapy, for Treating Platinum-Resistant Ovarian Cancer

What this Trial Is About

Researchers are evaluating the safety and best dose of OPB-101, a new treatment for women with platinum-resistant ovarian cancer. This phase 1ab clinical trial focuses on patients whose cancer has returned within six months after platinum-based chemotherapy and who have already received multiple prior treatments. The study uses a special type of therapy where a patients own T cells are modified in a lab to better fight cancer, specifically targeting mesothelin, a protein found on cancer cells. The treatment involves giving participants a one-time infusion of OPB-101, which is an autologous mesothelin CAR T cell therapy designed to express a specific IL-2 cytokine. Patients will be hospitalized to receive this infusion and then monitored closely at the clinical site over the following months. The study does not use a placebo and focuses solely on the experimental OPB-101 treatment. Participants will have regular safety checks, including laboratory tests and clinical evaluations, especially within the first 28 days and continuing up to two years after treatment. Researchers will assess how safe the therapy is over this time. The study requires participants to provide tumor tissue samples and undergo various health assessments like heart function tests, oxygen levels, and infection screening. The total participation time spans from the initial treatment day through extended follow-up visits for safety monitoring.

A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer