NY-ESO-1, a member of the cancer-testis family of tumor antigens, is expressed in ∼ 70% of Synovial Sarcoma (SS) cases. NY-ESO-1c259 SPEAR T-cellsTM recognizing the NY-ESO-1 derived SLLMWITQC peptide complexed with HLA-A*02 have been developed for study in SS.
The primary endpoint of overall response rate [ORR (CR + PR)] will be evaluated in high NY-ESO expressers [2 + , 3+ NY-ESO in ≥50% of tumor cells by IHC (Cohorts 1, 3, and 4)] and low expressers [1+ in >1%, 2 + , 3+ in
Enrollment in cohort 1 is complete (12 pts), ongoing in cohorts 2 and 3 (2 in each). ORR in cohort 1 is 50% (1 CR; 5 PR). Two pts receiving non target doses (
The NY-ESO-1c259 SPEAR T-cellsTM have promising efficacy and acceptable safety profile in pts with SS who highly express NY-ESO. Efficacy and safety data will be further evaluated and presented from subjects enrolled in all cohorts.
Clinical trial identification
Legal entity responsible for the study
K. Chagin, M. Mehler, G. Kari, T. Trivedi, T. Holdich, R. Amado: Author is an employee of Adaptimmune. L. Pandite: I am an employee of Adaptimmune. All other authors have declared no conflicts of interest.