Phase 1 Study of Autologous MUC1-Activated T Cells Given by IV to Treat Relapsed or Resistant Ovarian and Related Cancers

What this Trial Is About

Researchers are studying autologous MUC1-activated T cells in patients with relapsed or resistant ovarian cancer that expresses the MUC1 protein. This phase I trial aims to find the safest dose and evaluate preliminary effects of these T cells, which are made from the patients own blood cells and designed to target tumor cells. The study also explores the immune response, safety, and feasibility of producing and administering these cells in this patient population. Participants undergo a dose-escalation treatment process starting with leukapheresis to collect blood cells, followed by chemotherapy with cyclophosphamide or bendamustine given intravenously over several days. Then they receive the MUC1-activated T cells through an IV infusion on day 0 or on days 0 and 21. The trial includes monitoring with echocardiography or MUGA scans, blood tests, and imaging such as CT, MRI, or PETCT as needed. Ascites samples may also be collected during treatment and follow-up. During the study, participants will have follow-up visits at 30 and 60 days after day 28, then every three months for up to two years. Assessments include blood samples, imaging scans, and evaluations of side effects, immune responses, and tumor changes. Researchers will measure dose-limiting toxicities, maximum tolerated dose, and objective response rates. Safety monitoring includes checking for neurotoxicity and cytokine release syndrome. Hospital resource use and health economics will also be assessed throughout the study.

MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer