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Study of KITE-363 in Participants With Relapsed and/or Refractory B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04989803
Recruitment Status : Recruiting
First Posted : August 4, 2021
Last Update Posted : April 24, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Study Description
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Brief Summary:
The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-363, in participants with relapsed and/or refractory B-cell lymphoma.

Condition or disease Intervention/treatment Phase
Relapsed and/or Refractory B-cell Lymphoma Drug: Cyclophosphamide Drug: Fludarabine Biological: KITE-363 Phase 1

Detailed Description:
Five years after the last study participant is randomized, participants who have received an infusion of KITE-363 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
Actual Study Start Date : October 27, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : January 2041

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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.

 Drug: Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously

Drug: Fludarabine
Lymphodepleting chemotherapy administered intravenously

Biological: KITE-363
A single infusion of CAR-transduced autologous T cells administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
    DLTs are defined as the KITE-363-related events with onset within the first 28 days after the infusion of KITE-363.

  2. Phase 1b: Objective Response Rate (ORR) [ 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 Measures :
  1. Percentage of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 15 years ]
  2. Percentage of Participants Experiencing Serious AEs (SAEs) [ Time Frame: Up to 15 years ]
  3. Time To Next Treatment (TTNT) [ Time Frame: Up to 15 years ]
    TTNT is defined as the time from KITE-363 infusion to the next anticancer treatment (including stem cell transplantation [SCT]) or death from any cause, whichever occurs first.

  4. Complete Response (CR) Rate [ 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) [ 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) [ Time Frame: Up to 15 years ]
    PFS is defined as the time of KITE-363 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) [ Time Frame: Up to 15 years ]
    OS is defined as the time from KITE-363 infusion to death from any cause.

  8. Percentage of Participants who Develop Antibodies to KITE-363 CAR [ Time Frame: Enrollment; up to 12 months ]
  9. Levels of KITE-363 Chimeric Antigen Receptor (CAR) T Cells 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Relapsed and/or refractory B-cell lymphoma (R/R BCL).
  • At least 1 measurable lesion.
  • Adequate organ and bone marrow (BM) function.

Key Exclusion Criteria:

  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
  • History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
  • History of allogeneic stem cell transplant (allo-SCT).
  • Auto-SCT within 6 weeks before the planned KITE-363 infusion.
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B (hepatitis B surface antigen positive) infection, or hepatitis C (anti-hepatitis C virus [HCV] positive) infection.
  • Individuals with detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or a history of central nervous system (CNS) lymphoma, primary CNS lymphoma, or spinal epidural involvement.
  • History or presence of a CNS disorder.
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
  • Primary immunodeficiency.
  • History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 2 years.
  • History of non-line associated, clinically significant deep-vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within the 6 months before enrollment.
  • Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04989803


Contacts
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Contact: Medical Information 844-454-5483(1-844-454-KITE) medinfo@kitepharma.com

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
United States, California
Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
United States, Maryland
University of MD, Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
United States, Texas
The University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
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Study Director: Kite Study Director Kite, A Gilead Company
More Information
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Additional Information:

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Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT04989803    
Other Study ID Numbers: KT-US-499-0150
2020-000562-41 ( EudraCT Number )
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
 Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists