Cyclophosphamide
DrugLymphodepleting chemotherapy administered intravenously
NCT Number: NCT04989803
The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria: for Phase 1a/b and Phase 2
Key Exclusion Criteria: for Phase 1a/b and Phase 2
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Lymphodepleting chemotherapy administered intravenously
Lymphodepleting chemotherapy administered intravenously
A single infusion of CAR-transduced autologous T cells administered intravenously
A single infusion of CAR-transduced autologous T cells administered intravenously
Time frame: Up to 28 days
DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.
Time frame: Up to 15 years
ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.
Time frame: Up to 15 years
Time frame: Up to 15 years
Time frame: Up to 15 years
Time frame: Up to 15 years
TTNT is defined as the time from KITE-363 or KITE-753 infusion to the next anticancer treatment (including stem cell transplantation [SCT]) or death from any cause, whichever occurs first.
Time frame: Up to 15 years
CR rate is defined as the incidence of a CR by the IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.
Time frame: Up to 15 years
DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression per the IWG Lugano Classification or death due to any cause, whichever occurs first.
Time frame: Up to 15 years
PFS is defined as the time of KITE-363 or KITE-753 infusion to disease progression per IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) or death from any cause, whichever occurs first.
Time frame: Up to 15 years
OS is defined as the time from KITE-363 or KITE-753 infusion to death from any cause.
Time frame: Enrollment; up to 12 months
Time frame: Up to 15 years
Time frame: Up to 3 months
Time frame: Up to 3 months
IFN-γ=Interferon-Gamma, IL-1 Receptor Antagonist=IL-1RA
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 3 months
Time frame: Up to 15 years
Time frame: Up to 15 years
Time frame: Up to 15 years
Time frame: Up to 15 years
Time frame: Up to 15 years
Time frame: Up to 15 years
Contact information is provided by the study sponsor or research team.
Kite, A Gilead Company
Industry
A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
Acronym: PALISADES-1
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.