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NCT Number: NCT04989803

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal North Shore Hospital, St Leonards, New South Wales, Australia

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About this study

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.

Who can participate

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

  • 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: for Phase 1a/b and Phase 2

  • History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
  • 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 allogeneic stem cell transplant (allo-SCT).
  • Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 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 virus (HBV) (hepatitis B surface [HBs] antigen [HBsAg] positive) infection, or hepatitis C (anti-hepatitis C virus [HCV] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.
  • Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma.
  • 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 90 days.
  • Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and/or transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.
  • 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.

Treatment and study plan

Cyclophosphamide

Drug

Lymphodepleting chemotherapy administered intravenously

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

Primary outcomes

  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 and KITE-753 as per investigator's assessment.

    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.

  3. Phase 2: ORR as per central assessment for KITE-753

    Time frame: Up to 15 years

Secondary outcomes

  1. Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753

    Time frame: Up to 15 years

  2. Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753

    Time frame: Up to 15 years

  3. Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and 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. Phase 1a/b: Complete Response (CR) Rate for KITE-363 and 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. Phase 1a/b: Duration of Response (DOR) for KITE-363 and 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. Phase 1a/b: Progression-Free Survival (PFS) for KITE-363 and 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. Phase 1a/b: Overall Survival (OS) for KITE-363 and 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. Phase 1a/b: Percentage of Participants who Develop Antibodies to KITE-363 and KITE-753 Chimeric Antigen Receptor (CAR) T Cells

    Time frame: Enrollment; up to 12 months

  9. Phase 1a/b: Levels of KITE-363 and KITE-753 CAR T Cells

    Time frame: Up to 15 years

  10. Phase 1a/b: Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15

    Time frame: Up to 3 months

  11. 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)

    Time frame: Up to 3 months

    IFN-γ=Interferon-Gamma, IL-1 Receptor Antagonist=IL-1RA

  12. Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP)

    Time frame: Up to 3 months

  13. Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Ferritin

    Time frame: Up to 3 months

  14. Phase 1a/b: 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. 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)

    Time frame: Up to 3 months

  16. Phase 1a/b: Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme B

    Time frame: Up to 3 months

  17. Phase 2: CR rate for KITE-753

    Time frame: Up to 15 years

  18. Phase 2: DOR for KITE-753

    Time frame: Up to 15 years

  19. Phase 2: PFS for KITE-753

    Time frame: Up to 15 years

  20. Phase 2: OS for KITE-753

    Time frame: Up to 15 years

  21. Phase 2: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-753

    Time frame: Up to 15 years

  22. Phase 2: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-753

    Time frame: Up to 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

844-454-5483(1-844-454-KITE)

Sponsors and collaborators

Lead sponsor

Kite, A Gilead Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Aug 4, 2021
Registry last updated
Jun 29, 2026

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.