NCT03462316

NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor (TCR) Affinity Enhancing Specific T Cell in Bone and Soft Tissue Sarcoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this trial is to investigate the safety and tolerability of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone and soft tissue sarcoma. The secondary purpose of this trial is to investigate the efficacy of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone and soft tissue sarcoma.

Detailed description

This is a one arm, open label, dose escalation, single dose phase I study. The investigators include first-line treatment failed advanced patients with bone or soft tissue sarcoma and without standard regimen;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. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on bone and soft tissue sarcoma is still unknown. So the investigators plan to explore its efficacy. The patients must meet the two criteria: HLA-A\*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry. By this trial, the dose-limiting toxicity (DLT) and maximum tolerance (MTD) will be initially identified.

Conditions

• Bone Sarcoma
• 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: 2018-05-21
• Primary completion: 2024-02-15
• Completion: 2024-05-15
• First posted: 2018-03-12
• Last updated: 2023-04-12

Locations

1 site across 1 country: China