Clinical trial NCT03912831: Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)
timeFrame: First infusion date of KITE-439 up to 21 days
measure: Phase 1B: Objective Response Rate (ORR)
timeFrame: Up to 1.4 years
Secondary outcomes:
measure: Phase 1B: Duration of Response (DOR)
timeFrame: Up to 1.4 years
measure: Phase 1B: Progression-Free Survival (PFS)
timeFrame: Up to 1.4 years
measure: Phase 1B: Overall Survival
timeFrame: Up to 1.4 years
measure: Phase 1B: Percentage of Participants Experiencing Adverse Events
timeFrame: Up to 1.4 years
measure: Phase 1B: Percentage of Participants With Anti-KITE-439 Antibodies
timeFrame: Up to 1.4 years
measure: Phase 1B: Percentage of Participants With Replication-competent Retrovirus (RCR)
timeFrame: Up to 1.4 years
measure: Phase 1B: Levels of E7 TCR T Cells
timeFrame: Up to 1.4 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Kite, A Gilead Company
name: Kite Study Director
role: STUDY_DIRECTOR
References:
citation: Kirtane K; Massarelli E; Hanna GJ; et al KITE-439: A Phase 1 Study of HPV16 E7 T Cell Receptor-engineered T Cells in Patients with Relapsed/Refractory HPV16-positive Cancers. ASCO Poster 2020