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

  • Interventional
  • Recruiting
  • NCT03912831
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Key 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

        Key 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

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.

At a Glance

National Government IDNCT03912831

IRB#IRB18-1725

Lead SponsorKite, A Gilead Company

Lead PhysicianMichael R. Bishop

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting