Neoplasms

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Gland and Hormone Related Diseases

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Thyroid Neoplasms

Thyroid Diseases

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Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Liver Neoplasms

Soft Tissue Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

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Digestive System Neoplasms

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Antineoplastic Agents

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All Drugs and Chemicals

Hematinics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Liver Extracts

Patients who meet the inclusion criteria receive TAEST16001treatment after lymphodepleting by fludarabine and cyclophosphamide.

After completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001

TAEST16001

Jian Zhang

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.

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.

a single-center, open, single (or fractional) dose of safety and tolerability

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors

Application of NY-ESO-1-specific TCR Affinity Enhancing Specific T Cell Therapy (TAEST16001) in Solid Tumors Except Non Small Cell Lung Cancer,Including Liver Cancer,Gastric Cancer,Esophageal Cancer and so on.

The treatment-related adverse events of the patients received TAEST16001 treatment will be assessed by CTCAE v4.03

The overall response rate is evaluated according to Response Evaluation Criteria In Solid Tumors or Immune Related Response Criteria

The efficacy of TAEST16001 will be assessed by duration of response(DOR).The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.

The efficacy of TAEST16001 will be assessed by time to progress (TTP).The TTP refers to the time from treatment to disease progression

The efficacy of TAEST16001 will be assessed by progression free survival (PFS).The PFS refers to the time from treatment to progressive disease or death for any reason

The efficacy of TAEST16001 will be assessed by overall survival (OS).The OS refers to the time from treatment to death

The efficacy of TAEST16001 will be assessed by tumor markers including carcinoembryonic antigen,carbohydrate antigen199,carbohydrate antigen125,prostate specific antigen,alpha fetoprotein,carbohydrate antigen724.

Xiangxue Life Science Research Center

Guangdong Xiangxue Precision Medical Technology Co., Ltd.

Xiangxue Pharmaceutical

Zhujiang Hospital

Spots Global Cancer Trial Database for bladder carcinoma stage iv