A Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T cells against Cancer-testis Antigens in Metastatic Melanoma
Diseases and Conditions Researched
What is the purpose of this trial?
This proof of concept (phase 1) clinical trial will test the hypothesis that enhanced TCRs are safe and can promote tumor regression after non-myeloablative chemotherapy in patients with metastatic melanoma. This trial incorporates several improvements in T cell manufacturing that should streamline the development of adoptive T cell therapy. In addition, extensive correlative laboratory studies are included for proof of concept.The primary efficacy endpoints are response by RECIST criteria and progression free survival. There will be 6 patients in each of 2 study groups (NY-ESO-1 positive and MAGE-3 positive), and the goal is to estimate the efficacy endpoints within each group, rather than comparing them with one another. In this case, the effective sample size for each test or confidence interval is 6 patients.
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