NCT05304208

dENdritic Cell Therapy Combined With SURgEry in Mesothelioma

Phase I, Open-Label Study With Dendritic Cell Therapy (MesoPher) In Combination With Ex-tended-Pleurectomy/Decortication After Chemotherapy in Subjects With Resectable Mesothelioma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ENSURE trial is an open label, single center, phase 1, feasibility study. Sixteen adult patients diagnosed with resectable epithelioid malignant pleural mesothelioma (MPM) will be enrolled following first-line chemotherapy. Before standard-of-care chemotherapy, a leukapheresis will be performed and monocytes will be used for differentiation to dendritic cells (DCs) using specific cytokines. Allogeneic tumor lysate (Pheralys) loaded autologous DCs (MesoPher) will be re-injected 3 weeks after completing chemotherapy, 2 times every other week. Four weeks after the first injection with dendritic cell therapy (DCT), patients will undergo extrapleural pleurectomy/decortication (eP/D) surgery and receive three bi-weekly injections with DCT (starting 4 weeks after surgery). In total, five DC vaccinations will be administered. A tumor biopsy will be collected before starting neo-adjuvant DCT.

Conditions

• Mesotheliomas Pleural

Interventions

Type	Name	Description
BIOLOGICAL	Mesopher	autologous monocyte-derived DCs loaded with PheraLys (tumor cell lysate)

Timeline

• Start date: 2021-11-02
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-03-31
• Last updated: 2025-04-25

Locations

1 site across 1 country: Netherlands