Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
NCT ID: NCT06079164
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
39 participants
INTERVENTIONAL
2023-11-09
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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KITE-197
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-197 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-197.
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-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable.
KITE-197
A single infusion of CAR-transduced autologous T cells administered intravenously
Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
Fludarabine
Lymphodepleting chemotherapy administered intravenously
Interventions
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KITE-197
A single infusion of CAR-transduced autologous T cells administered intravenously
Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
Fludarabine
Lymphodepleting chemotherapy administered intravenously
Eligibility Criteria
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Inclusion Criteria
* At least 1 measurable lesion
* Adequate organ and bone marrow function
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital
South Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Cross Cancer Institute
Edmonton, , Canada
QEII Health Sciences Centre
Halifax, , Canada
Jewish General Hospital
Montreal, , Canada
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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KT-US-656-0601
Identifier Type: -
Identifier Source: org_study_id
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