The primary objectives of Phase 1A are to evaluate the safety of KITE-718, determine a recommended Phase 1B dose, and to evaluate the efficacy of KITE-718 in Phase 1B.
Participants found to be human leukocyte antigen (HLA)-DPB1\*04:01 positive and whose tumors are MAGE-A3 and/or MAGE-A6 positive can participate if all eligibility criteria are met. Other tests required to determine eligibility include a physical exam, electrocardiogram (ECG) and echocardiogram (ECHO) of the heart, CT or MRI scans, and blood draws. Eligible participants have white blood cells collected by leukapheresis. These cells are genetically modified to make the experimental treatment KITE-718. The desired outcome is that the genetically modified T cells will target tumor cells that express MAGE-A3 and/or MAGE-A6, which are proteins that can be expressed by cancer cells. Participants receive chemotherapy prior to the KITE-718 infusion. After the KITE-718 infusion, participants will be followed for side effects and have scans performed to see any potential impact on their cancers. Study procedures may be performed while hospitalized and/or in the outpatient setting. Subjects who received an infusion of KITE-718 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
A single infusion of autologous genetically modified MAGE-A3/A6 T-cell receptor (TCR) transduced autologous T cells (KITE-718).
Administered intravenously
Administered intravenously
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities
Dose-limiting toxicity is defined as protocol-defined KITE-718 related events with onset within the first 21 days following KITE-718 infusion.
Time frame: Up to 21 days
Phase 1B - Efficacy: Objective Response Rate (ORR)
ORR is defined as complete response + partial response for participants evaluated by RECIST v1.1 and very good partial response (VGPR) or better for multiple myeloma participants evaluated by International Myeloma Working Group (IMWG) Consensus Panel 1 Criteria.
Time frame: Up to year 2 for solid tumor participants and up to Year 5 for multiple myeloma participants
Duration of Response (DOR)
For participants who experience an objective response, DOR is defined as the time from the date of their first objective response to the date of disease progression per modified RECIST v1.1 or consensus panel 1 criteria or death regardless of cause.
Time frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants
Progression-Free Survival (PFS)
PFS is defined as the time from the KITE-718 infusion date to the date of disease progression per modified RECIST v1.1 or consensus panel 1 criteria or death from any cause.
Time frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants
Overall Survival
Overall survival is defined as the time from KITE-718 infusion to the date of death.
Time frame: Up to 15 years
Percentage of Participants Experiencing Adverse Events
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A screening test for MAGE-A3/A6+ tumors
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Baylor Scott & White Charles A. Sammons Cancer Center
Dallas, Texas, United States
...and 2 more locations
Time frame: Up to 15 years
Percentage of Participants with Anti-KITE-718 Antibodies
Time frame: Up to 2 years
Percentage of Participants Experiencing Replication-competent Retrovirus (RCR)
Time frame: Up to 2 years
Levels of MAGE-A3/A6 TCR-transduced T Cells in Blood
Time frame: Up to 2 years