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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
A single infusion of E7 TCR T cells (KITE-439).
Administered intravenously.
Administered intravenously.
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
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.
Time frame: First infusion date of KITE-439 up to 21 days
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.
Time frame: Up to 1.4 years
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.
Time frame: Up to 1.4 years
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.
Time frame: Up to 1.4 years
Phase 1B: Overall Survival
Overall survival was defined as the time from KITE-439 infusion to the date of death.
Time frame: Up to 1.4 years
Phase 1B: Percentage of Participants Experiencing Adverse Events
Time frame: Up to 1.4 years
Phase 1B: Percentage of Participants With Anti-KITE-439 Antibodies
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Administered subcutaneously.
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
Time frame: Up to 1.4 years
Phase 1B: Percentage of Participants With Replication-competent Retrovirus (RCR)
Time frame: Up to 1.4 years
Phase 1B: Levels of E7 TCR T Cells
Time frame: Up to 1.4 years