Phase II Study of TAEST16001 in Soft Tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is a single-arm, open label, multi-center, phase II study. The investigators include advanced soft tissue sarcoma with failure in standard treatment or no recommended standard therapy.

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 patients and 55% melanoma patients benefit from this treatment, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy.

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. NY-ESO-1 expression was also found in 88.2% of myxoid liposarcomas, 61.1% of synovial sarcomas, 31.3% of osteosarcomas, 21.4% of pleomorphic liposarcomas, 16.7% of desmoplastic small round cell tumors, and 14.3% of chondrosarcomas. Although the NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients and the phase I trial has been performed, its effect and safety on advanced soft tissue sarcoma is still unknown.

The patients must meet the two criteria: HLA-A*0201positive and NY-ESO-1 positive cells≥20% by immunohistochemistry. ;

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

• NCT number: NCT05549921
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Xing Zhang, PhD, MD
• Phone: 862087343192
• Email: zhangxing@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: July 8, 2022
• Completion date: September 1, 2024