NY-ESO-1 TCR （TAEST16001）for Patients With Advanced NSCLC
Status:
Unknown status
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Guangzhou Institute of Respiratory Disease
Collaborators:
Guangdong Xiangxue Precision Medical Technology Co., Ltd. Guangzhou Xiangxue Pharmaceutical Co., Ltd Xiangxue Life Science Research Center Xiangxue Pharmaceutical