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
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown 2172563, New South Wales 2155400 2050
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
South Brisbane 2207259, Queensland 2152274 4101
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 3004
AustraliaSite Not Available
Cross Cancer Institute
Edmonton, T6G 1Z2
CanadaSite Not Available
Cross Cancer Institute
Edmonton 5946768, T6G 1Z2
CanadaSite Not Available
QEII Health Sciences Centre
Halifax, B3H 2Y9
CanadaSite Not Available
QEII Health Sciences Centre
Halifax 6324729, B3H 2Y9
CanadaSite Not Available
Jewish General Hospital
Montreal 6077243, H3T 1E2
CanadaSite Not Available
Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont
Montréal, H1T 2M4
CanadaSite Not Available
Jewish General Hospital
Montréal, H3T 1E2
CanadaSite Not Available
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesSite Not Available
Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
United StatesSite Not Available
Henry-Joyce Cancer Clinic
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
St. David's South Austin Medical Center
Austin, Texas 78704
United StatesSite Not Available
St. David's South Austin Medical Center
Austin 4671654, Texas 4736286 78704
United StatesSite Not Available
Swedish Cancer Institute
Seattle, Washington 98104
United StatesSite Not Available
Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available

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