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

Last updated: December 23, 2024
Sponsor: Kite, A Gilead Company
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma, B-cell

Lymphoma

Treatment

KITE-753

Fludarabine

KITE-363

Clinical Study ID

NCT04989803
KT-US-499-0150
2020-000562-41
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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.

Exclusion

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 (withthe exception of hormonal therapy in the case of breast cancer) for at least 3years.

  • History of Richter's transformation of chronic leukemic lymphoma, small lymphocyticlymphoma, or lymphoplasmacytic lymphoma.

  • 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 orrequires 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.

  • Individuals with detectable cerebrospinal fluid (CSF) malignant cells or brainmetastases or a history of central nervous system (CNS) lymphoma, primary CNSlymphoma, 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 heartfailure or other clinically significant cardiac disease within the 6 months beforeenrollment.

  • Primary immunodeficiency.

  • History of autoimmune disease resulting in or requiring systemic immunosuppressionand/or systemic disease-modifying agents within the last 2 years.

  • History of non-line associated, clinically significant deep-vein thrombosis orpulmonary embolism requiring therapeutic anticoagulation within the 6 months beforeenrollment.

  • Females of childbearing potential who are pregnant or breastfeeding because of thepotentially dangerous effects of the preparative chemotherapy on the fetus orinfant. Females who have undergone surgical sterilization or have beenpostmenopausal for at least 2 years are not considered to be of childbearingpotential.

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

Study Design

Total Participants: 114
Treatment Group(s): 4
Primary Treatment: KITE-753
Phase: 1
Study Start date:
October 27, 2021
Estimated Completion Date:
July 31, 2026

Study Description

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.

Connect with a study center

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Universitatsklinikum Wurzburg

    Wuerzburg, 97080
    Germany

    Active - Recruiting

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Stanford Cancer Institute

    Stanford, California 94305
    United States

    Active - Recruiting

  • Northside Hospital

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • University of MD, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center - James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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