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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kite, A Gilead Company
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

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.