drugset / Trial / NCT01697527

Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies

NCT01697527

Phase 2 Active not recruiting 6 enrolled Jonsson Comprehensive Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial will examine whether genetically reprogramming a patient's disease fighting white blood cells may build an immune response to kill cancer cells that express the NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell transplant along with a vaccine therapy. The vaccine will be made using the NY-ESO-1 protein and may help to stimulate the engineered immune response to tumor cells.

Timeline

Start
2012-11-02
Primary completion
2026-11-02
Completion
2027-11-02

Drugs

EvaluationDrugModalityDoseRoute
Subject NY-ESO-1 Reactive TCR Retroviral Vector Transduced Autologous PBL Cell therapy 1e+09 cells Intravenous
Subject dendritic cell vaccine therapy Vaccine Intramuscular
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous
Background aldesleukin Protein / enzyme biologic Subcutaneous

Indications