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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000562-41 | EudraCT Number | ||
| 2024-511616-24 | Other Identifier | CTIS Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 a/b: KITE-363 | Experimental | 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. [Recruitment completed for this arm] |
|
| Phase 1 a/b: KITE-753 | Experimental | 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. [Recruitment open for frontline LBCL and r/r MCL for this arm] |
|
| Phase 2: KITE-753 | Experimental | Participants with r/r large B-cell lymphoma who have received at least 2 prior lines of systemic therapy 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 /kg intravenously (IV). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Lymphodepleting chemotherapy administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753 | 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. | Up to 28 days |
| Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment. | 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. | Up to 15 years |
| Phase 2: ORR as per central assessment for KITE-753 | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753 | Up to 15 years | |
| Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753 | Up to 15 years |
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Key Inclusion Criteria: for Phase 1a/b and Phase 2
Key Exclusion Criteria: for Phase 1a/b and Phase 2
- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | 844-454-5483(1-844-454-KITE) | medinfo@kitepharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States | |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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|
| Fludarabine | Drug | Lymphodepleting chemotherapy administered intravenously |
|
| KITE-363 | Biological | A single infusion of CAR-transduced autologous T cells administered intravenously |
|
| KITE-753 | Biological | A single infusion of CAR-transduced autologous T cells administered intravenously |
|
| Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and KITE-753 | 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. | Up to 15 years |
| Phase 1a/b: Complete Response (CR) Rate for KITE-363 and KITE-753 | 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. | Up to 15 years |
| Phase 1a/b: Duration of Response (DOR) for KITE-363 and KITE-753 | 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. | Up to 15 years |
| Phase 1a/b: Progression-Free Survival (PFS) for KITE-363 and KITE-753 | 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. | Up to 15 years |
| Phase 1a/b: Overall Survival (OS) for KITE-363 and KITE-753 | OS is defined as the time from KITE-363 or KITE-753 infusion to death from any cause. | Up to 15 years |
| Phase 1a/b: Percentage of Participants who Develop Antibodies to KITE-363 and KITE-753 Chimeric Antigen Receptor (CAR) T Cells | Enrollment; up to 12 months |
| Phase 1a/b: Levels of KITE-363 and KITE-753 CAR T Cells | Up to 15 years |
| Phase 1a/b: Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15 | Up to 3 months |
| Phase 1a/b: 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) | IFN-γ=Interferon-Gamma, IL-1 Receptor Antagonist=IL-1RA | Up to 3 months |
| Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP) | Up to 3 months |
| Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Ferritin | Up to 3 months |
| Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Soluble IL-2 Receptor Alpha (Sil-2Rα) | Up to 3 months |
| Phase 1a/b: 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) | Up to 3 months |
| Phase 1a/b: Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme B | Up to 3 months |
| Phase 2: CR rate for KITE-753 | Up to 15 years |
| Phase 2: DOR for KITE-753 | Up to 15 years |
| Phase 2: PFS for KITE-753 | Up to 15 years |
| Phase 2: OS for KITE-753 | Up to 15 years |
| Phase 2: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-753 | Up to 15 years |
| Phase 2: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-753 | Up to 15 years |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| Stanford Cancer Institute | Recruiting | Stanford | California | 94305 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
| Midwestern Regional Medical Center, Inc.City of Hope Chicago | Recruiting | Park Ridge | Illinois | 60068 | United States |
| Norton Cancer Institute, St. Matthews Campus | Recruiting | Shelbyville | Kentucky | 40065 | United States |
| University of MD, Greenebaum Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21201 | United States |
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
| The Ohio State University Wexner Medical Center - James Cancer Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
| Tennessee Oncology, PLLC - Investigational Drug Services | Recruiting | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University | Recruiting | Nashville | Tennessee | 37232 | United States |
| St. David's Medical Center | Recruiting | Austin | Texas | 78704 | United States |
| The University of Texas, MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
| Royal North Shore Hospital | Recruiting | St Leonards | New South Wales | 2065 | Australia |
| Concord Repatriation General Hospital | Recruiting | Sydney | New South Wales | 2139 | Australia |
| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
| Epworth Healthcare | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| Jewish General Hospital | Recruiting | Montreal | H3T 1E2 | Canada |
| McGill University Health Center | Recruiting | Montreal | H4A 0B1 | Canada |
| Universitatsklinikum Wurzburg | Recruiting | Würzburg | 97080 | Germany |
| Academisch Medisch Centrum | Recruiting | Amsterdam | 1105 AZ | Netherlands |
| King's College Hospital | Completed | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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