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NCT Number: NCT06079164

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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About this study

Participants will be followed for approximately 6 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Relapsed or Refractory Large B-cell Lymphoma
  • At least 1 measurable lesion
  • Adequate organ and bone marrow function

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 the exception of individuals who have previously achieved an objective response to such therapy and their tumor expresses CD19 by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (IHC) at the time of screening. 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 is uncontrolled 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 exclusion criterion.
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months before enrollment
  • Presence of primary immunodeficiency
  • History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
  • History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3 months before enrollment. Catheter induced DVT which has been treated for at least 6 weeks prior to enrollment is permitted
  • Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant

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

Treatment and study plan

KITE-197

Drug

A single infusion of CAR-transduced autologous T cells administered intravenously

Cyclophosphamide

Drug

Lymphodepleting chemotherapy administered intravenously

Fludarabine

Drug

Lymphodepleting chemotherapy administered intravenously

Primary outcomes

  1. Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)

    Time frame: First infusion date of KITE-197 up to 28 days

  2. Phase 1b: Complete Remission (CR) Rate

    Time frame: Up to 24 months

    Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.

Secondary outcomes

  1. Percentage of Participants Experiencing Adverse Events (AEs)

    Time frame: Enrollment up to 24 months plus 30 days

  2. Percentage of Participants Experiencing Serious Adverse Events (SAEs)

    Time frame: Enrollment up to 24 months plus 30 days

  3. Overall Response Rate (ORR)

    Time frame: Up to 24 months

    ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma therapy, per the Lugano Classification, as determined by the investigator.

  4. Duration of Response (DOR)

    Time frame: Up to 24 months

    DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.

  5. Progression-Free Survival (PFS)

    Time frame: Up to 24 months

    PFS is defined as the time from KITE-197 infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.

  6. Event Free Survival (EFS)

    Time frame: Up to 24 months

    EFS is defined as the time from KITE-197 infusion to the earliest occurrence of death due to any cause, disease progression/relapse per investigator, or initiation of new anti-lymphoma therapy.

  7. Time to Next Treatment (TTNT)

    Time frame: Up to 24 months

    TTNT is defined as time from KITE-197 infusion to the start of subsequent new lymphoma therapy or death from any cause.

  8. Overall Survival (OS)

    Time frame: Up to 24 months

    OS is defined as the time from KITE-197 infusion to death from any cause.

  9. Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion

    Time frame: Up to 24 months

  10. Proportion of Immune Cell Subsets in KITE-197

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Kite, A Gilead Company

Industry

Registry information

Official study title

A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Jan 8, 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.

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