KITE-197
DrugA single infusion of CAR-transduced autologous T cells administered intravenously
NCT Number: NCT06079164
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A single infusion of CAR-transduced autologous T cells administered intravenously
Lymphodepleting chemotherapy administered intravenously
Lymphodepleting chemotherapy administered intravenously
Time frame: First infusion date of KITE-197 up to 28 days
Time frame: Up to 24 months
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: Enrollment up to 24 months plus 30 days
Time frame: Enrollment up to 24 months plus 30 days
Time frame: Up to 24 months
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
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
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
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
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
OS is defined as the time from KITE-197 infusion to death from any cause.
Time frame: Up to 24 months
Time frame: Up to 24 months
Kite, A Gilead Company
Industry
A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07711483
B-Cell Lymphomas, Disease Attributes
Boston, Massachusetts, United States
View Trial DetailsNCT07606937
Disease Attributes, Pathologic Processes
Beijing, Beijing Municipality, China
View Trial DetailsNCT05800977
Disease Attributes, Pathologic Processes
Beijing, China
View Trial DetailsNCT06414148
Disease Attributes, Hemic and Lymphatic Diseases
Camperdown, New South Wales, Australia
View Trial Details