Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer Clinical Trial
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
| Verified date | December 2023 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | February 18, 2022 |
| Est. primary completion date | February 18, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | City of Hope | Duarte | California |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
| United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs) | A DLT is defined as protocol-defined KITE-439 related Grade 3 events with onset within the first 21 days following KITE-439 infusion and which do not resolve to =Grade 2 events within 48 hours, =Grade 4 events with onset within the first 21 days following KITE-439 infusion, regardless of duration. | First infusion date of KITE-439 up to 21 days | |
| Primary | Phase 1B: Objective Response Rate (ORR) | ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as evaluated by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to 1.4 years | |
| Secondary | Phase 1B: Duration of Response (DOR) | For participants who experience an objective response, DOR was defined as the time from the date of their first objective response to the date of disease progression per modified RECIST v1.1 or death from any cause. | Up to 1.4 years | |
| Secondary | Phase 1B: Progression-Free Survival (PFS) | PFS was defined as the time from the KITE-439 infusion date to the date of disease progression per modified RECIST v1.1 or death from any cause. | Up to 1.4 years | |
| Secondary | Phase 1B: Overall Survival | Overall survival was defined as the time from KITE-439 infusion to the date of death. | Up to 1.4 years | |
| Secondary | Phase 1B: Percentage of Participants Experiencing Adverse Events | Up to 1.4 years | ||
| Secondary | Phase 1B: Percentage of Participants With Anti-KITE-439 Antibodies | Up to 1.4 years | ||
| Secondary | Phase 1B: Percentage of Participants With Replication-competent Retrovirus (RCR) | Up to 1.4 years | ||
| Secondary | Phase 1B: Levels of E7 TCR T Cells | Up to 1.4 years |