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A pilot trial using lymphocytes genetically engineered with an NY-ESO-1-reactive T-cell receptor: long-term follow-up
Paul F Robbins1, Sadik H Kassim2, Thai L N Tran3
1NIH, National Cancer Institute, Surgery Branch, Bethesda, Maryland. Paul_Robbins@nih.gov.
Purpose:
Although adoptive cell therapy can be highly effective for the treatment of patients with melanoma, the application of this approach to the treatment of other solid tumors has been limited. The observation that the cancer germline (CG) antigen NY-ESO-1 is expressed in 70% to 80% and in approximately 25% of patients with synovial cell sarcoma and melanoma, respectively, prompted us to perform this first-in-man clinical trial using the adoptive transfer of autologous peripheral blood mononuclear cells that were retrovirally transduced with an NY-ESO-1-reactive T-cell receptor (TCR) to heavily pretreated patients bearing these metastatic cancers.
Experimental Design:
HLA-*0201 patients with metastatic synovial cell sarcoma or melanoma refractory to standard treatments and whose cancers expressed NY-ESO-1 received autologous TCR-transduced T cells following a lymphodepleting preparative chemotherapy. Response rates using Response Evaluation Criteria in Solid Tumors (RECIST), as well as immunologic correlates of response, are presented in this report.
Results:
Eleven of 18 patients with NY-ESO-1(+) synovial cell sarcomas (61%) and 11 of 20 patients with NY-ESO-1(+) melanomas (55%) who received autologous T cells transduced with an NY-ESO-1-reactive TCR demonstrated objective clinical responses. The estimated overall 3- and 5-year survival rates for patients with synovial cell sarcoma were 38% and 14%, respectively, whereas the corresponding estimated survival rates for patients with melanoma were both 33%.
Conclusions:
The adoptive transfer of autologous T cells transduced with a retrovirus encoding a TCR against an HLA-A*0201 restricted NY-ESO-1 epitope can be an effective therapy for some patients bearing synovial cell sarcomas and melanomas that are refractory to other treatments.
Insights
Adoptive cell therapy using NY-ESO-1 reactive T-cell receptors (TCRs) showed promise for metastatic synovial cell sarcoma and melanoma. This treatment led to objective clinical responses in over half of the patients studied.
Area of Science:
- Oncology
- Immunotherapy
- Cellular Therapy
Background:
- Adoptive cell therapy (ACT) is effective for melanoma but limited for other solid tumors.
- NY-ESO-1 antigen is expressed in synovial cell sarcoma (70-80%) and melanoma (25%).
Purpose of the Study:
- To evaluate the safety and efficacy of adoptive transfer of autologous T cells transduced with an NY-ESO-1-reactive TCR.
- To assess treatment outcomes in patients with metastatic synovial cell sarcoma and melanoma refractory to standard therapies.
Main Methods:
- First-in-man clinical trial involving heavily pretreated patients with metastatic cancers expressing NY-ESO-1.
- Autologous peripheral blood mononuclear cells were retrovirally transduced with an NY-ESO-1-reactive TCR.
- Patients received lymphodepleting chemotherapy followed by TCR-transduced T cells.
Main Results:
- Objective clinical responses observed in 61% of synovial cell sarcoma patients and 55% of melanoma patients.
- Estimated 3-year survival rates were 38% for synovial cell sarcoma and 33% for melanoma.
- Estimated 5-year survival rates were 14% for synovial cell sarcoma and 33% for melanoma.
Conclusions:
- Adoptive transfer of NY-ESO-1 TCR-transduced T cells is an effective therapy for some patients with refractory synovial cell sarcoma and melanoma.
- This approach offers a potential treatment option for patients with advanced solid tumors expressing the NY-ESO-1 antigen.
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