OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

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

PHASE1PHASE2RECRUITING

The goal of this clinical study is to learn more about the safety and dosing of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

  1. 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.
  2. History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
  3. History of allogeneic stem cell transplant (allo-SCT).
  4. Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
  5. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
  6. 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.
  7. 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.
  8. History or presence of a CNS disorder.
  9. 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.
  10. Primary immunodeficiency.
  11. History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 2 years.
  12. History of non-line associated, clinically significant deep-vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within the 6 months before enrollment.
  13. 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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study ID

NCT04989803

Intervention or treatment

DRUG: Cyclophosphamide

DRUG: Fludarabine

BIOLOGICAL: KITE-363

BIOLOGICAL: KITE-753

Conditions

  • Relapsed and/or Refractory B-cell Lymphoma

  • Condition: Relapsed and/or Refractory B-cell Lymphoma

  • DRUG: Cyclophosphamide and other drugs

  • St Leonards, New South Wales, Australia

  • Sponsor: Kite, A Gilead Company

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Royal North Shore Hospital

Select from list below to view details:

  • Royal North Shore Hospital

    St Leonards, New South Wales, Australia

Loading map...

Who is running the clinical trial?

KAGC

Kite, A Gilead Company

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Phase 1 a/b: 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.
  • \[Recruitment completed for this arm\]
Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-363
    EXPERIMENTAL: Phase 1 a/b: 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.
    • \[Recruitment open for frontline LBCL and r/r MCL for this arm\]
    Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-753
      EXPERIMENTAL: Phase 2: KITE-753
      • 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).
      Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-753

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime Frame
        Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753DLTs 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 or KITE-753ORR 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

        Secondary Outcome

        MeasureDescriptionTime Frame
        Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 or KITE-753Not SpecifiedUp to 15 years
        Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 or KITE-753Not SpecifiedUp to 15 years
        Time To Next Treatment (TTNT) for KITE-363 or KITE-753TTNT 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
        Complete Response (CR) Rate for KITE-363 or KITE-753CR 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
        Duration of Response (DOR) for KITE-363 or KITE-753DOR 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
        Progression-Free Survival (PFS) for KITE-363 or KITE-753PFS 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
        Overall Survival (OS) for KITE-363 or KITE-753OS is defined as the time from KITE-363 or KITE-753 infusion to death from any cause.Up to 15 years
        Percentage of Participants who Develop Antibodies to KITE-363 or KITE-753 Chimeric Antigen Receptor (CAR) T CellsNot SpecifiedEnrollment; up to 12 months
        Levels of KITE-363 or KITE-753 CAR T Cells and Analytes (Including Cytokines) in the BloodNot SpecifiedUp to 15 years
        Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15Not SpecifiedUp to 3 months
        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-1RAUp to 3 months
        Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP)Not SpecifiedUp to 3 months
        Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: FerritinNot SpecifiedUp to 3 months
        Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Soluble IL-2 Receptor Alpha (Sil-2Rα)Not SpecifiedUp to 3 months
        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)Not SpecifiedUp to 3 months
        Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme BNot SpecifiedUp to 3 months
        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
        Claim this trial

        References

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

        Other trials to consider

        Loading suggested trials...

        Top searched conditions

        Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular