[Translation] A multicenter, open, single-arm, phase II clinical study of TAEST16001 in the treatment of advanced soft tissue sarcoma with positive tumor antigen NY-ESO-1 expression and HLA-A*02:01 genotype

1) 主要目的以独立的影像评估委员会（IRC）评估的客观缓解率（ORR）为终点（基于实体肿瘤的疗效评价标准1.1版[RECIST1.1]）评价TAEST16001细胞治疗组织基因型为HLA-A*02:01且肿瘤抗原NY-ESO-1表达阳性的晚期软组织肉瘤患者的疗效。

[Translation]

1) Primary objective To evaluate the efficacy of TAEST16001 cell therapy in patients with advanced soft tissue sarcoma whose tissue genotype is HLA-A*02:01 and whose tumor antigen NY-ESO-1 is positive, using the objective response rate (ORR) assessed by an independent imaging review committee (IRC) as the endpoint (based on Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST1.1]).

Start Date18 Jul 2022

Sponsor / Collaborator

Guangdong Xiangxue Precision Medical Technology Co., Ltd.

NCT05549921 / RecruitingPhase 2IIT

TAEST16001 in Patients With Soft Tissue Sarcoma With Positive NY-ESO-1 Expression (Genotype: HLA-A*02:01): an Multi-center, Open-label and Single Arm Phase II Study

The main purpose of this trial is to evaluate the efficacy and safety of TAEST16001 cells in the treatment of advanced soft tissue sarcoma patients with HLA-A*02:01 tissue genotype and positive tumor antigen NY-ESO-1 expression.

Start Date08 Jul 2022

Sponsor / Collaborator

Sun Yat-Sen University

[+1]

CTR20192611 / Active, not recruitingPhase 1

TAEST16001细胞免疫治疗以软组织肉瘤为主的晚期恶性实体瘤患者的开放式单中心安全性和有效性评价早期临床试验

[Translation] An open single-center early clinical trial evaluating the safety and efficacy of TAEST16001 cell immunotherapy in patients with advanced malignant solid tumors, mainly soft tissue sarcomas

主要目的：评价TAEST16001注射液即NY-ESO-1特异性高亲和性T细胞受体转导的自体T细胞对NY-ESO-1表达阳性复发难治性恶性实体瘤患者（以软组织肉瘤为主）的安全性和耐受性；次要目的：通过对全血TCR-T细胞的免疫及活性检测，分析TCR-T细胞在体内的存活的持续时间及在细胞中随着时间的推移的存活度。初步评价TAEST16001注射液对NY-ESO-1表达阳性恶性实体瘤的有效性。

[Translation]

The primary objective is to evaluate the safety and tolerability of TAEST16001 injection, i.e., autologous T cells transduced with NY-ESO-1-specific high-affinity T cell receptors, in patients with NY-ESO-1-positive relapsed and refractory malignant solid tumors (mainly soft tissue sarcomas). The secondary objective is to analyze the duration of TCR-T cell survival in vivo and the survival rate in cells over time through the immune and activity detection of whole blood TCR-T cells. The effectiveness of TAEST16001 injection on NY-ESO-1-positive malignant solid tumors is preliminarily evaluated.

Start Date23 Mar 2020

Sponsor / Collaborator

Guangdong Xiangxue Precision Medical Technology Co., Ltd.

100 Clinical Results associated with TAEST-16001

100 Translational Medicine associated with TAEST-16001

100 Patents (Medical) associated with TAEST-16001

Literatures (Medical) associated with TAEST-16001

01 Aug 2023·Cell Reports Medicine

Phase 1 clinical trial to assess safety and efficacy of NY-ESO-1-specific TCR T cells in HLA-A∗02:01 patients with advanced soft tissue sarcoma

Article

Author: Lau, Johnson Y N ; Ou, Yusheng ; Pan, Qiuzhong ; Peng, Ruiqing ; Chen, Jiewen ; Zhang, Xing ; Han, Zhaosheng ; Zeng, Lun ; Fan, Zhengfu ; Gong, Haiping ; Wen, Xizhi ; Ma, Ke ; Xu, Bushu ; Que, Yi ; Yang, Jing ; Li, Yi ; Liu, Jiayong ; Weng, Desheng ; Chen, Aiyuan ; Lin, Yanmei ; Zhong, Shi

New York esophageal squamous cell carcinoma-1 (NY-ESO-1)-specific T cell receptor (TCR) T cell therapy is effective in tumors with NY-ESO-1 expression, but a safe and effective TCR-T cell therapeutic protocol remains to be improved. Here, we report a phase 1 investigational new drug clinical trial with TCR affinity-enhanced specific T cell therapy (TAEST16001) for targeting NY-ESO-1. Enrolled patients receive TAEST16001 cell infusion after dose-reduced lymphodepletion with cyclophosphamide (15 mg/kg/day × 3 days) combined with fludarabine (20 mg/m²/day × 3 days), and the TCR-T cells are maintained with low doses of interleukin-2 injection post-adoptive transfer. Analysis of 12 patients treated with the regimen demonstrates no treatment-related serious adverse events. The overall response rate is 41.7%. The median progression-free survival is 7.2 months, and the median duration of response is 13.1 months. The protocol of TAEST16001 cells delivers a safe and highly effective treatment for patients with advanced soft tissue sarcoma (ClinicalTrials.gov: NCT04318964).

100 Deals associated with TAEST-16001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Non-Small Cell Lung Cancer	Phase 3	CN	Xiangxue Pharmaceutical Co., Ltd.	21 Mar 2017
Soft Tissue Sarcoma	Phase 2	CN	Guangdong Xiangxue Precision Medical Technology Co., Ltd.	08 Jul 2022
Advanced Malignant Solid Neoplasm	Phase 1	CN	Guangdong Xiangxue Precision Medical Technology Co., Ltd.	23 Mar 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04318964 (Pubmed) Manual	Phase 1	Locally Advanced Soft Tissue Sarcoma	12	TAEST16001+cyclophosphamide+fludarabine	(pgsucgahcn) = rnwxznlkxy hwfanjqxup (umljgqwxzd ) View more	Positive	15 Aug 2023
NCT04318964 (ASCO2022) Manual	Phase 1	Locally Advanced Soft Tissue Sarcoma	12	cyclophosphamide+fludarabine+NY-ESO-1–specific TCR T-cells (TAEST16001)	(gzdjrhazdg) = bgzevgvmtv nsyrbuzrmd (srlsjovbpl ) View more	Positive	02 Jun 2022

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