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
(1) Pan Q (2) Weng D (3) Liu J (4) Han Z (5) Ou Y (6) Xu B (7) Peng R (8) Que Y (9) Wen X (10) Yang J (11) Zhong S (12) Zeng L (13) Chen A (14) Gong H (15) Lin Y (16) Chen J (17) Ma K (18) Lau JYN (19) Li Y (20) Fan Z (21) Zhang X
(1) Pan Q (2) Weng D (3) Liu J (4) Han Z (5) Ou Y (6) Xu B (7) Peng R (8) Que Y (9) Wen X (10) Yang J (11) Zhong S (12) Zeng L (13) Chen A (14) Gong H (15) Lin Y (16) Chen J (17) Ma K (18) Lau JYN (19) Li Y (20) Fan Z (21) Zhang X
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).
Author Info:
(1) Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. (2) Melanoma an
d Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. (3) Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Bone and Soft Tissue Tumor, Peking University Cancer Hospital & Institute, 52 Fucheng Road, Beijing 100142, P.R. China. (4) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (5) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (6) Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. (7) Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. (8) Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. (9) Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. (10) Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. (11) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (12) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (13) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (14) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (15) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (16) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (17) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. (18) Axis Therapeutics, Ltd., Hong Kong SAR, P.R. China; Athenex, Conventus Building, 1001 Main Street, Suite 600, Buffalo, NY 14203, USA. (19) Xiangxue Life Science Technology (Guangdong) Co., Ltd., Guangzhou 510663, P.R. China. Electronic address: li_yi@gibh.ac.cn. (20) Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Bone and Soft Tissue Tumor, Peking University Cancer Hospital & Institute, 52 Fucheng Road, Beijing 100142, P.R. China. Electronic address: zhengfufan@126.com. (21) Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. Electronic address: zhangxing@sysucc.org.cn.
