Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed / Refractory HPV16+ Cancers

Status: Active


This study has 2 parts: 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 in human leukocyte antigen (HLA)-A*02:01+ adults with relapsed / refractory human papillomavirus (HPV)16+ cancers.

Eligibility Criteria

Inclusion Criteria

  • Advanced cancer defined as relapsed or refractory disease after at least 1 line of therapy that included systemic chemotherapy and that is not amenable to definitive locoregional therapy
  • HPV16+ tumor as confirmed by the central laboratory
  • HLA type is HLA-A*02:01+ per local assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

  • Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management
  • Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor
  • Primary immunodeficiency
  • History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
  • Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) and/or nucleic acid testing

Locations & Contacts


City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available


Moffitt Cancer Center
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available


M D Anderson Cancer Center
Status: Active
Name Not Available


Fred Hutch / University of Washington Cancer Consortium
Status: In review
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type


Lead Organization

Lead Organization
Kite, A Gilead Company

Trial IDs

Primary ID KT-US-478-0401
Secondary IDs NCI-2019-02810 ID NCT03912831