A Phase II Study of ADP-A2M4 Gene Therapy in People with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

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Full Title

A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Purpose

The purpose of this study is to evaluate the safety and effectiveness of ADP-A2M4, an investigational gene therapy, in people with advanced synovial sarcoma or myxoid/round cell liposarcoma. ADP-A2M4 is made by removing white blood cells called T cells from the patient, genetically modifying them in the laboratory, and then giving the modified T cells back to the patient so they will be able to attack and kill cancer cells.

Patients in this study will receive the chemotherapy drugs fludarabine and cyclophosphamide to prepare the body to receive ADP-A2M4 treatment. All of the treatments used 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 myxoid/round cell liposarcoma.
  • Patients’ cancers must persist despite prior chemotherapy.
  • Patients’ tumors must contain the MAGE-4 protein.
  • Patients must be positive for HLA-A2.
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • 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 16-75.

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

Protocol

19-316

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators