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Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT03912831•Gilead Sciences

View on ClinicalTrials.gov

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 adults who are human leukocyte antigen (HLA)-A\*02:01+ and have relapsed/refractory human papillomavirus (HPV)16+ cancers.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (9)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Key Dates

Start Date

April 30, 2019

Primary Completion Date

February 18, 2022

Completion Date

February 18, 2022

Last Updated

December 26, 2023

Enrollment

ACTUAL participants

Conditions

Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer

Interventions

KITE-439

DRUG

Cyclophosphamide

DRUG

Fludarabine

DRUG

Interleukin-2

DRUG