Full TitleMaster Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination with Other Agents, in Participants with Advanced Tumors
The purpose of this study is to find out whether two modified T-cell treatments, GSK3901961 and GSK3845097, are safe and effective for people with advanced synovial sarcoma or non-small cell lung cancer (NSCLC). GSK3901961 and GSK3845097 are made from modified versions of a patient’s own T cells (white blood cells that are part of the immune system). The T cells are altered so they can target two proteins, NY-ESO-1 and LAGE-1a, which are found in some synovial sarcomas and lung tumors.
This treatment approach is a form of immunotherapy. Patients will receive either GSK3901961 or GSK3845097. They will first have chemotherapy to prepare them for the T-cell therapy. The treatments in this study are given intravenously (by vein).
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 or NSCLC that makes the NY-ESO-1 and/or LAGE-1a proteins and cannot be successfully treated with standard therapies
- Patients should recover from the serious side effects of previous treatment before receiving the study treatment.
- 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 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Adam Schoenfeld at 646-608-4042.