NCT05549921

Phase II Study of TAEST16001 in Soft Tissue Sarcoma

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)	NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)

Timeline

• Start date: 2022-07-08
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-09-22
• Last updated: 2023-12-27

Locations

2 sites across 1 country: China