drugset / Trial / NCT03450122

Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma

NCT03450122

Phase 1 Completed 15 enrolled M.D. Anderson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes \[T cells\]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating participants with sarcoma that has spread to other places in the body (advanced) or that has come back (recurrent). Modified T cells used in this study are taken from participants, are changed in a laboratory, and may "kill" some types of tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide may help the body get ready to receive the modified T cells. Interleukins, such as aldesleukin, are proteins made by white blood cells and other cells in the body and may help regulate immune response. LV305 and CMB305 may help stimulate the immune system. Giving modified T cells, chemotherapy, aldesleukin, LV305, and CMB305 may work better in treating participants with sarcoma.

Timeline

Start
2018-09-13
Primary completion
2022-12-06
Completion
2022-12-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous NY-ESO-1-specific CD8-positive T Lymphocytes Cell therapy Intravenous
Subject ID-LV305 Unknown Other
Background Cyclophosphamide Other / unclassified Intravenous
Background aldesleukin Protein / enzyme biologic Subcutaneous