Kite Study Director Study Director Kite, A Gilead Company
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Medical Information Kontakt: Phone: 844-454-5483(1-844-454-KITE) E-Mail: medinfo@kitepharma.com» Kontaktdaten anzeigen
Studienlocations (3 von 9)
Universitatsklinikum Wurzburg 97080 Wuerzburg (Bayern) GermanyRekrutierend» Google-MapsBanner MD Anderson Cancer Center 85234 Gilbert United StatesRekrutierend» Google-MapsStanford Cancer Institute 94305 Stanford United StatesRekrutierend» Google-Maps
University of MD, Greenebaum Comprehensive Cancer Center 21201 Baltimore United StatesRekrutierend» Google-MapsColumbia University Irving Medical Center 10032 New York United StatesRekrutierend» Google-MapsUniversity of Rochester Medical Center 14642 Rochester United StatesRekrutierend» Google-MapsThe University of Texas, MD Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-MapsAcademisch Medisch Centrum 1105 AZ Amsterdam NetherlandsRekrutierend» Google-MapsKing's College Hospital SE5 9RS London United KingdomRekrutierend» Google-Maps
1. Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753 (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.
2. Phase 1b: Objective Response Rate (ORR) for KITE-363 or KITE-753 (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.
Secondary outcome:
1. Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 or KITE-753 (Time Frame - Up to 15 years)
2. Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 or KITE-753 (Time Frame - Up to 15 years)
3. Time To Next Treatment (TTNT) for KITE-363 or KITE-753 (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.
4. Complete Response (CR) Rate for KITE-363 or KITE-753 (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.
5. Duration of Response (DOR) for KITE-363 or KITE-753 (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.
6. Progression-Free Survival (PFS) for KITE-363 or KITE-753 (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.
7. Overall Survival (OS) for KITE-363 or KITE-753 (Time Frame - Up to 15 years): OS is defined as the time from KITE-363 or KITE-753 infusion to death from any cause.
8. Percentage of Participants who Develop Antibodies to KITE-363 or KITE-753 Chimeric Antigen Receptor (CAR) T Cells (Time Frame - Enrollment; up to 12 months)
9. Levels of KITE-363 or KITE-753 CAR T Cells and Analytes (Including Cytokines) in the Blood (Time Frame - Up to 15 years)
10. Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15 (Time Frame - Up to 3 months)
11. Peak Serum Levels of Key Analytes Inflammatory/Immune Modulating Cytokines: IFN-γ, IL-6, IL-10, IL-17, IL-1RA, Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), and Tumor Necrosis Factor-Alpha (TNF-α) (Time Frame - Up to 3 months): IFN-γ=Interferon-Gamma, IL-1 Receptor Antagonist=IL-1RA
12. Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP) (Time Frame - Up to 3 months)
13. Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Ferritin (Time Frame - Up to 3 months)
14. Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Soluble IL-2 Receptor Alpha (Sil-2Rα) (Time Frame - Up to 3 months)
15. Peak Serum Levels of Key Analytes Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1) (Time Frame - Up to 3 months)
16. Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme B (Time Frame - Up to 3 months)
Experimental: KITE-363 Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-363.
Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-363 at 1 or more dose-level deemed to be tolerable.
Experimental: KITE-753 Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-753.
Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-753 at 1 or more dose-level deemed to be tolerable.
