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 (SPEARHEAD 1 Study)
This is a study of genetically engineered ADP-A2M4 in HLA-A*02 subjects with metastatic or inoperable (advanced) Synovial Sarcoma or MRCLS who have received prior chemotherapy and whose tumor expresses the MAGE-A4 tumor antigen.
Primary: To evaluate the efficacy of autologous genetically modified T cells (ADP-A2M4) in HLA-A*02 positive subjects with MAGE-A4 expressing advanced synovial sarcoma or MRCLS Secondary: To evaluate the safety and tolerability of autologous genetically modified T cells (ADP-A2M4) in HLA-A*02 positive subjects with MAGE-A4 expressing advanced synovial sarcoma or MRCLS To evaluate the efficacy of autologous genetically modified T cells (ADP-A2M4) in HLA-A*02 positive subjects with MAGE-A4 expressing advanced synovial sarcoma or MRCLS Development and validation of an in vitro diagnostic (IVD) assay for the screening of tumor antigen expression for regulatory approval Characterize the in vivo cellular pharmacokinetics (PK) profile of ADPA2M4 cells Exploratory: To evaluate changes in health-related outcomes following treatment with ADPA2M4 Characterize subject peripheral blood, which includes, but is not limited to: transduced T cells (ADP-A2M4), nontransduced T cells, serum and/or plasma pre and post-T cell infusion, to understand factors that can influence response or resistance to ADP-A2M4 therapy. Characterize the tumor and tumor microenvironment pre and post- T cell infusion to understand tumor driven determinants of response and resistance to ADP-A2M4 therapy
Immunotherapy; Therapy (NOS)
ADP-A2M4 (); MESNA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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