TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute showed that 61% Synovial cell sarcoma and 55% melanoma had benefits, without severe side effects found in Chimeric Antigen Receptor T-Cell Immunotherapy treatment. The American FDA has approved TCR-T cell therapy for soft tissue sarcoma. The European Medicines Agency has approved the TCR-T cell therapy to enter the fast-track.
This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on other solid tumors is still unknown. So we plan to explore its efficacy in tumors including bone and soft tissue sarcoma, melanoma, liver cancer, esophageal cancer, breast cancer, thyroid and ovarian cancer.
The trial is to investigate the safety and tolerability of TAEST16001 cell therapy in multi-line treatment failed advanced solid tumors including bone and soft tissue sarcoma, melanoma, liver cancer, esophageal cancer, breast cancer, thyroid and ovarian cancer. The patients must meet the two criteria: HLA-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemisty. By this trial, the dose-limiting toxicity (DLT) and maximum tolerance (MTD) of TAEST16001 will be initially identified.