drugset / Trial / NCT02408016

Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma

NCT02408016

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of genetically modified T cells in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma. Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell from patients, called T cells, and modifies their genes in the laboratory so that they are programmed to find cells with WT1 and kill them. The T cells are then given back to the patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may help the body build an immune response to kill tumor cells.

Timeline

Start
2015-05-22
Primary completion
2020-06-30
Completion
2020-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes Cell therapy Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Background aldesleukin Protein / enzyme biologic Subcutaneous