Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma

Last updated: November 18, 2024
Sponsor: Kite, A Gilead Company
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma, B-cell

Lymphoma

Treatment

Cyclophosphamide

KITE-197

Fludarabine

Clinical Study ID

NCT06079164
KT-US-656-0601
  • Ages > 18
  • All Genders

Study Summary

This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL.

The primary objectives of this study are:

Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b.

Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Relapsed or Refractory Large B-cell Lymphoma

  • At least 1 measurable lesion

  • Adequate organ and bone marrow function

Exclusion

Key Exclusion Criteria:

  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg,cervix, bladder, breast) unless disease free for at least 2 years

  • History of Richter's transformation of chronic leukemic lymphoma

  • History of allogenic stem cell transplant (SCT)

  • Autologous SCT within 6 weeks of planned KITE-197 infusion

  • Prior CD19 targeted antibody, such as tafasitamab and loncastuximab with theexception of individuals who have previously achieved an objective response to suchtherapy and their tumor expresses CD19 by International Council for Harmonisation ofTechnical Requirements for Pharmaceuticals for Human Use (IHC) at the time ofscreening. Individuals who meet these criteria may be eligible

  • Prior treatment with bendamustine within 6 months of enrollment

  • Prior CAR therapy or other genetically modified cell therapy

  • Presence or suspicion of fungal, bacterial, viral, or other infection that isuncontrolled or requiring IV antimicrobials for management

  • History of HIV infection or acute or chronic active hepatitis B or C infection

  • History or presence of a clinically significant central nervous system (CNS)disorder Note: Prior or active CNS involvement by lymphoma is not an exclusioncriterion.

  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,New York Heart Association Class II or greater congestive heart failure, or otherclinically significant cardiac disease within 12 months before enrollment

  • Presence of primary immunodeficiency

  • History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemiclupus) resulting in end organ injury or requiring systemicimmunosuppression/systemic disease modifying agents within the last 2 years

  • History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3months before enrollment. Catheter induced DVT which has been treated for at least 6weeks prior to enrollment is permitted

  • Females of childbearing potential who are pregnant or breastfeeding because of thepotentially dangerous effects of the preparative chemotherapy on the fetus or infant

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

Study Design

Total Participants: 39
Treatment Group(s): 3
Primary Treatment: Cyclophosphamide
Phase: 1
Study Start date:
November 09, 2023
Estimated Completion Date:
January 31, 2028

Study Description

Participants will be followed for approximately 24 months after the infusion of KITE-197 before transitioning to a separate Kite long-term follow-up study KT-US-982-5968, in which they will be followed for the remainder of the 15-year follow-up period.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Royal Brisbane and Women's Hospital

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, T6G 1Z2
    Canada

    Active - Recruiting

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9
    Canada

    Active - Recruiting

  • Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont

    Montréal, H1T 2M4
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montréal, H3T 1E2
    Canada

    Site Not Available

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • St. David's South Austin Medical Center

    Austin, Texas 78704
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

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