A Study of Two Modified T-Cell Treatments in People with Advanced Sarcoma or Non-Small Cell Lung Cancer

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Full Title

Master 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

Purpose

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).

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 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.

Protocol

20-561

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators