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A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+Subjects with Relapsed/Refractory HPV16+ Cancers
Study KITE-439 is a Phase 1 study evaluating the safety and efficacy of KITE-439 in subjects who are HLA-A*02:01+ and have HPV16+ relapsed/refractory cancers. The trial is separated into 2 phases: Phase 1A and Phase 1B.
The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to estimate the efficacy of KITE-439, as measured by objective response rate (ORR). Secondary objectives include assessing the safety of KITE-439 and additional efficacy endpoints.
KITE-439 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)