Phase 1 Study of Dendritic Cell Therapy with Surgery After Chemotherapy for Treatable Epithelioid Pleural Mesothelioma

What this Trial Is About

Researchers are evaluating dendritic cell therapy combined with surgery in adult patients diagnosed with resectable epithelioid malignant pleural mesothelioma MPM who have completed first-line chemotherapy. This phase 1, open-label, single-center study aims to assess the feasibility of this new approach. The trial involves 16 patients and focuses on whether they can complete the combined treatment without major delays, serious side effects, or disease progression. Before starting standard platinum-based chemotherapy, patients undergo leukapheresis to collect monocytes that are then transformed into dendritic cells DCs using specific cytokines. These autologous DCs loaded with allogeneic tumor lysate MesoPher are injected twice every other week, beginning three weeks after chemotherapy ends. Four weeks after the first DC injection, patients have extrapleural pleurectomydecortication ePD surgery followed by three additional bi-weekly DC injections starting four weeks post-surgery. Up to seven total DC vaccinations may be given depending on availability and physician decision. Participants will have tumor biopsies taken before starting dendritic cell therapy and undergo various scans to confirm disease stage. Researchers will monitor survival, treatment side effects, and progression-free survival over two years. Patients are followed closely with regular assessments and must be able to attend all vaccinations and follow-up visits. Safety, tolerability, and feasibility of this combined therapy approach are the main outcomes measured.

dENdritic Cell Therapy Combined With SURgEry in Mesothelioma