Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
NCT ID: NCT04989803
Last Updated: 2026-01-07
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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RECRUITING
PHASE1/PHASE2
247 participants
INTERVENTIONAL
2021-10-27
2027-10-31
Brief Summary
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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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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.
\[Recruitment completed for this arm\]
Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
Fludarabine
Lymphodepleting chemotherapy administered intravenously
KITE-363
A single infusion of CAR-transduced autologous T cells administered intravenously
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.
\[Recruitment open for frontline LBCL and r/r MCL for this arm\]
Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
Fludarabine
Lymphodepleting chemotherapy administered intravenously
KITE-753
A single infusion of CAR-transduced autologous T cells administered intravenously
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).
Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
Fludarabine
Lymphodepleting chemotherapy administered intravenously
KITE-753
A single infusion of CAR-transduced autologous T cells administered intravenously
Interventions
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Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
Fludarabine
Lymphodepleting chemotherapy administered intravenously
KITE-363
A single infusion of CAR-transduced autologous T cells administered intravenously
KITE-753
A single infusion of CAR-transduced autologous T cells administered intravenously
Eligibility Criteria
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Inclusion Criteria
* At least 1 measurable lesion.
* Adequate organ and bone marrow (BM) function.
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 (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
* History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, 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 or requires 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 brain metastases or a history of central nervous system (CNS) lymphoma, primary CNS lymphoma, 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 heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
* Primary immunodeficiency.
* History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 2 years.
* History of non-line associated, clinically significant deep-vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within the 6 months before enrollment.
* 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.
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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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Stanford Cancer Institute
Stanford, California, United States
Northside Hospital
Atlanta, Georgia, United States
University of MD, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Universitatsklinikum Wurzburg
Würzburg, , Germany
Academisch Medisch Centrum
Amsterdam, , Netherlands
King's College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2020-000562-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511616-24
Identifier Type: OTHER
Identifier Source: secondary_id
KT-US-499-0150
Identifier Type: -
Identifier Source: org_study_id
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