A Phase IIB Study of NY-ESO-1 T-Cell Immunotherapy in Patients with Advanced Myxoid/Round Cell Liposarcoma

Full Title

A Phase 2b Single Arm Open Label Clinical Trial of NY-ESO-1c259T Cells in Subjects with Advanced Myxoid/ Round Cell Liposarcoma A Phase 2B Single Arm Open Label Clinical Trial of NY-ESO-1c259T in Subjects with Advanced Myxoid/ Round Cell Liposarcoma

Purpose

Myxoid liposarcoma is challenging to treat successfully. Doctors are therefore seeking more effective therapies. The purpose of this study is to assess the safety and effectiveness of an investigational immunotherapy in which a patient's immune cells are altered in a laboratory and given back to the patient with the hope of provoking an immune response against myxoid liposarcoma.

NY-ESO-1 is a protein found on many liposarcomas. In this study, some of a patient's T cells (a type of white blood cell) will be removed and modified with a gene that makes them recognize liposarcoma cells containing NY-ESO-1. This approach is called "T-cell receptor gene therapy."

Patients will first have chemotherapy with cyclophosphamide and fludarabine. They will then receive the NY-ESO-1-modified T cells. Researchers will determine if this therapy is safe and see if the altered T cells can kill myxoid liposarcoma cells.

Eligibility

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

  • Patients must have metastatic or inoperable high-grade myxoid liposarcoma that has continued to grow or came back despite prior therapy.
  • Patients' tumors must contain the NY-ESO-1 protein.
  • Patients must be positive for HLA-A2.
  • At least 4 weeks must pass between the completion of previous treatments and entry into the study, and patients must recover from any serious side effects.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Sandra P. D'Angelo at 646-888-4159.

Protocol

16-1406

Phase

II

Investigator

Co-Investigators

Locations