Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
Cyclophosphamide
KITE-197
Fludarabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Relapsed or Refractory Large B-cell Lymphoma
At least 1 measurable lesion
Adequate organ and bone marrow function
Exclusion
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 theexception of individuals who have previously achieved an objective response to suchtherapy and their tumor expresses CD19 by International Council for Harmonisation ofTechnical Requirements for Pharmaceuticals for Human Use (IHC) at the time ofscreening. 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 isuncontrolled 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 exclusioncriterion.
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,New York Heart Association Class II or greater congestive heart failure, or otherclinically significant cardiac disease within 12 months before enrollment
Presence of primary immunodeficiency
History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemiclupus) resulting in end organ injury or requiring systemicimmunosuppression/systemic disease modifying agents within the last 2 years
History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3months before enrollment. Catheter induced DVT which has been treated for at least 6weeks prior to enrollment is permitted
Females of childbearing potential who are pregnant or breastfeeding because of thepotentially dangerous effects of the preparative chemotherapy on the fetus or infant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Royal Brisbane and Women's Hospital
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Cross Cancer Institute
Edmonton, T6G 1Z2
CanadaActive - Recruiting
QEII Health Sciences Centre
Halifax, B3H 2Y9
CanadaActive - Recruiting
Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont
Montréal, H1T 2M4
CanadaActive - Recruiting
Jewish General Hospital
Montréal, H3T 1E2
CanadaSite Not Available
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesActive - Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
United StatesActive - Recruiting
St. David's South Austin Medical Center
Austin, Texas 78704
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle, Washington 98104
United StatesActive - Recruiting
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