A Phase II Study of GSK3377794 in People with Advanced Synovial Sarcoma

Share
Print

Full Title

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination with Other Agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug GSK3377794 in people with inoperable or metastatic synovial sarcoma containing certain types of proteins. GSK3377794 is made by taking some T cells from a patient, modifying them in the laboratory to recognize a protein on some sarcoma tumors called NY-ESO-1, and returning the modified T cells to the patient so they can find and kill sarcoma cells.

Before receiving GSK3377794, patients will receive chemotherapy to destroy some of their immune cells, which helps GSK3377794 fight cancer more effectively. GSK3377794 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic synovial sarcoma that produces NY-ESO-1
  • Patients may be newly diagnosed or have recurrent synovial sarcoma after receiving prior treatment.
  • Patients must be positive for the HLA-A2 protein in their blood.
  • Previously treated patients must recover from the serious side effects of prior therapies before entering the study.
  • Prior treatment with any therapy targeting NY-ESO-1, gene therapy, or a donated stem cell transplant is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 10 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sandra P. D’Angelo at 646-888-4159.

Protocol

20-055

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators