Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Key Inclusion Criteria:
- Relapsed or Refractory Large B-cell Lymphoma
- At least 1 measurable lesion
- Adequate organ and bone marrow function
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 the
exception of individuals who have previously achieved an objective response to such
therapy and their tumor expresses CD19 by International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (IHC) at the time of
screening. 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 is
uncontrolled 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 exclusion
criterion.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,
New York Heart Association Class II or greater congestive heart failure, or other
clinically significant cardiac disease within 12 months before enrollment
- Presence of primary immunodeficiency
- History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic
lupus) resulting in end organ injury or requiring systemic
immunosuppression/systemic disease modifying agents within the last 2 years
- History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3
months before enrollment. Catheter induced DVT which has been treated for at least 6
weeks prior to enrollment is permitted
- Females of childbearing potential who are pregnant or breastfeeding because of the
potentially dangerous effects of the preparative chemotherapy on the fetus or infant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.