drugset / Trial / NCT02414945

TILs & Low-Dose IL-2 Therapy Following Cyclophosphamide and Fludarabine in Pleural Mesothelioma Patients

NCT02414945

Phase 1/2 Completed 9 enrolled University Health Network, Toronto
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I and II clinical study for patients with malignant pleural mesothelioma (a type of cancer affecting the lining of the lung). Patients will receive an infusion (given by vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down. Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the TILs. After cell infusion, patients will receive low-dose interleukin-2 therapy. This study will see how safe and useful this regimen is in treating malignant pleural mesothelioma.

Timeline

Start
2015-05-15
Primary completion
2020-10
Completion
2020-10

Drugs

EvaluationDrugModalityDoseRoute
Subject LM103 Cell therapy 1e+10 cells Intravenous
Subject LM103 Cell therapy 1.6e+11 cells Intravenous
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background aldesleukin Protein / enzyme biologic 125000 iu/kg Subcutaneous