Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
KITE-753
Fludarabine
KITE-363
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key 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
Key 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 (withthe exception of hormonal therapy in the case of breast cancer) for at least 3years.
History of Richter's transformation of chronic leukemic lymphoma, small lymphocyticlymphoma, 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 orrequires 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 brainmetastases or a history of central nervous system (CNS) lymphoma, primary CNSlymphoma, 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 heartfailure or other clinically significant cardiac disease within the 6 months beforeenrollment.
Primary immunodeficiency.
History of autoimmune disease resulting in or requiring systemic immunosuppressionand/or systemic disease-modifying agents within the last 2 years.
History of non-line associated, clinically significant deep-vein thrombosis orpulmonary embolism requiring therapeutic anticoagulation within the 6 months beforeenrollment.
Females of childbearing potential who are pregnant or breastfeeding because of thepotentially dangerous effects of the preparative chemotherapy on the fetus orinfant. Females who have undergone surgical sterilization or have beenpostmenopausal for at least 2 years are not considered to be of childbearingpotential.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Royal North Shore Hospital
St Leonards, New South Wales 2065
AustraliaSite Not Available
Universitatsklinikum Wurzburg
Wuerzburg, 97080
GermanyActive - Recruiting
Academisch Medisch Centrum
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
King's College Hospital
London, SE5 9RS
United KingdomActive - Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United StatesActive - Recruiting
Stanford Cancer Institute
Stanford, California 94305
United StatesActive - Recruiting
Northside Hospital
Atlanta, Georgia 30342
United StatesActive - Recruiting
University of MD, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Columbia University Irving Medical Center
New York, New York 10032
United StatesActive - Recruiting
University of Rochester Medical Center
Rochester, New York 14642
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio 43210
United StatesActive - Recruiting
The University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesActive - Recruiting
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