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MechanismNY-ESO-1 inhibitors |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
MechanismT lymphocyte replacements |
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Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
TAEST1901注射液治疗基因型为 HLA-A*02:01,肿瘤抗原 AFP表达为阳性的晚期肝癌或其它晚期肿瘤开放式 、安全性和有效评价I期临床试验
[Translation] TAEST1901 Injection is an open, safety and effective phase I clinical trial for the treatment of advanced liver cancer or other advanced tumors whose genotype is HLA-A*02:01 and the expression of tumor antigen AFP is positive
主要目的:
研究TAEST1901治疗基因型为HLA-A*02:01,肿瘤抗原AFP表达为阳性的晚期肝癌或其它晚期肿瘤受试者的安全性和耐受性。 次要目的:
1.研究TAEST1901治疗基因型为HLA-A*02:01,肿瘤抗原AFP表达为阳性的晚期肝癌或其它晚期肿瘤受试者的初步有效性。
2.研究TAEST1901细胞回输人体后的药代动力学(PK)特征、药效动力学(PD)特征,观察其在体内的增殖和持续性,以及对人体免疫学活性的影响。
3.研究TAEST1901治疗前后受试者体内的AFP表达及慢病毒的复制情况。
[Translation] main purpose:
To study the safety and tolerability of TAEST1901 in treating subjects with advanced liver cancer or other advanced tumors whose genotype is HLA-A*02:01 and the expression of tumor antigen AFP is positive. Secondary purpose:
1. To study the preliminary effectiveness of TAEST1901 in treating subjects with advanced liver cancer or other advanced tumors whose genotype is HLA-A*02:01 and the expression of tumor antigen AFP is positive.
2. Study the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of TAEST1901 cells after infusion into the human body, observe their proliferation and persistence in vivo, and their impact on human immunological activity.
3. To study the expression of AFP and the replication of lentivirus in the subjects before and after TAEST1901 treatment.
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 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.
Pilot Study of Affinity-enhanced Anti-NY-ESO-1 TCR Engineered Autologous T Cells in NSCLC Patients
TCR-T cell therapy experienced a breakthrough for treating 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 therapeutic responses. Another report of a phase I / II clinical trial for multiple myeloma showed that 20 patients received high affinity anti-NY-ESO-1 and LAGE-1 specific TCR-T treatment, 16 of them (80%) had the average progression-free survival of 19.1 months with minor side effect. These achievements indicate that TCR-T cell therapy can target a variety of tumors including solid tumors without any severe side effects found in CAR-T trials.
This study is mainly focused on tumor testis antigen (Cancer-Testis Antigen), because it is not expressed in normal cells. NY-ESO-1 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 cell sarcoma. Approximately 700,000 new cases of lung cancer are identified each year in China, 70% of them die within one to two years after diagnosis due to the lack of effective treatment. To address that unmet needs, our TCR-T treatment targets non-small cell lung cancer with NY-ESO-1 antigen expression.
This study will investigate the safety and tolerability of TAEST16001 (TAEST: TCR Affinity Enhancing Specific T cell Therapy, autologous T cells transduced with affinity enhanced NY-ESO-1 TCR) cell therapy in subjects with NSCLC who have received prior therapy for their disease but their disease has progressed or relapsed.
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