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Open label non-randomized multi-cohort pilot study of genetically engineered NY-ESO-1 specific NY-ESO-1c259 SPEAR T-cellsTM in HLA-A*02+ patients with synovial sarcoma (NCT01343043)

Date

09 Oct 2016

Session

Poster display

Presenters

Crystal Mackall

Citation

Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378

Authors

C. Mackall1, S. D'Angelo2, S. Grupp3, J. Glod4, M. Druta5, W. Chow6, K. Chagin7, M. Mehler8, G. Kari8, T. Trivedi8, T. Holdich9, L. Pandite8, R. Amado8

Author affiliations

  • 1 Stanford Cancer Institute, Stanford University Medical Center, 94305 - Stanford/US
  • 2 Medicine, Memorial Sloan Kettering Cancer Center, New York/US
  • 3 Pediatrics, Children's Hospital of Philadelphia, Philadelphia/US
  • 4 Center For Cancer Research, National Cancer Institute, Washington/US
  • 5 Oncology, Moffitt Cancer Center, Tampa/US
  • 6 Medical Oncology, City of Hope, Duarte/US
  • 7 Global Clinical Development, Adaptimmune, Philadelphia/US
  • 8 Global Clinical Development, Adaptimmune LLC, Philadelphia/US
  • 9 Global Clinical Development, Adaptimmune LTD, Oxford/GB
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Resources

Background

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.

Methods

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

Results

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 (

Conclusions

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

NCT01343043

Legal entity responsible for the study

Adaptimmune LLC

Funding

Adaptimmune LLC

Disclosure

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.

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