To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors
Condition: Liver Cancer Stage IV; Gastric Cancer Stage IV; Esophageal Cancer, Stage IV; Bone and Soft Tissue Tumors; Breast Cancer Stage IV; Bladder Carcinoma Stage IV; Prostate Carcinoma Stage IV; Thyroid Cancer Stage IV; Ovarian Cancer Stage IV; Solid Tumor
MeSH terms: Carcinoma; Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Urinary Bladder Neoplasms; Soft Tissue Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this trial is to investigate the safety and tolerability of
      TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed
      advanced solid tumors except non small cell lung cancer,including liver cancer,gastric
      cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder
      carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet
      the two criteria: human leukocyte antigens (HLA)-A*0201+ and NY-ESO-1 positive cells≥25% by
      immunohistochemistry.
    

Detailed description: 
      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 T cell receptor (TCR)
      transduced T-Cell Immunotherapy. The US FDA has granted breakthrough TCR-T cell therapy for
      patients with inoperable or metastatic synovial sarcoma. The European Medicines Agency has
      also approved the same therapy to Priority Medicines(PRIME).

      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 many
      types of solid tumors.

      The trial is to investigate the safety and tolerability of TAEST16001 cell therapy in
      multi-line treatment failed advanced solid tumors except non small cell lung cancer,including
      liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer,
      bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients
      must meet the two criteria: HLA-A*0201+ and NY-ESO-1 positive cells≥25% by
      immunohistochemistry.
    

Intervention name(s): TAEST16001
Intervention type(s): Drug
Intervention description(s): After completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001
Intervention model: Single Group Assignment
Intervention model description: a single-center, open, single (or fractional) dose of safety and tolerability
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TAEST16001