This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL. The primary objectives of this study are: Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b. Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.
Participants will be followed for approximately 6 months after the infusion of KITE-197 before transitioning to a separate Kite long-term follow-up study KT-US-982-5968, in which they will be followed for the remainder of the 15-year follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
A single infusion of CAR-transduced autologous T cells administered intravenously
Lymphodepleting chemotherapy administered intravenously
Lymphodepleting chemotherapy administered intravenously
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital
South Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Cross Cancer Institute
Edmonton, Canada
QEII Health Sciences Centre
Halifax, Canada
...and 1 more locations
Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Time frame: First infusion date of KITE-197 up to 28 days
Phase 1b: Complete Remission (CR) Rate
Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
Time frame: Up to 24 months
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: Enrollment up to 24 months plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Enrollment up to 24 months plus 30 days
Overall Response Rate (ORR)
ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma therapy, per the Lugano Classification, as determined by the investigator.
Time frame: Up to 24 months
Duration of Response (DOR)
DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.
Time frame: Up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from KITE-197 infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.
Time frame: Up to 24 months
Event Free Survival (EFS)
EFS is defined as the time from KITE-197 infusion to the earliest occurrence of death due to any cause, disease progression/relapse per investigator, or initiation of new anti-lymphoma therapy.
Time frame: Up to 24 months
Time to Next Treatment (TTNT)
TTNT is defined as time from KITE-197 infusion to the start of subsequent new lymphoma therapy or death from any cause.
Time frame: Up to 24 months
Overall Survival (OS)
OS is defined as the time from KITE-197 infusion to death from any cause.
Time frame: Up to 24 months
Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion
Time frame: Up to 24 months
Proportion of Immune Cell Subsets in KITE-197
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.