Full TitleA 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
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).
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.