LAST UPDATED
June 29, 2026
Clinicaltrials.gov ID
EudraCT ID
CTSID
OVERVIEW
A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma (PALISADES-1)
PROTOCOL SUMMARY
The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Relapsed and/or Refractory B-cell Lymphoma
Gender
N/A
Date
October 2021 - February 2030
Study Type
Interventional
Study Phase
Phase 1, Phase 2
Product
Cyclophosphamide, Fludarabine, KITE-363, KITE-753
Eligibility information
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 criteria
- \- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
- 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 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. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.
- Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma.
- 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 90 days.
- Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and/or transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (26)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Stanford Cancer Institute
Stanford, California, United States, 94305
Midwestern Regional Medical Center, Inc.City of Hope Chicago
Park Ridge, Illinois, United States, 60068
Norton Cancer Institute, St. Matthews Campus
Shelbyville, Kentucky, United States, 40065
University of MD, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Columbia University Irving Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, United States, 43210
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, United States, 37203
Vanderbilt University
Nashville, Tennessee, United States, 37232
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Concord Repatriation General Hospital
Sydney, New South Wales, Australia, 2139
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
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