To learn if the combination of axicabtagene ciloleucel (axi-cel) and glofitamab as first-line therapy in high-risk LBCL participants or as second-line therapy in LBCL participants can help to control the disease.
Histologically proven CD19- and CD20-positive LBCL, including transformation from indolent lymphomas.
Have disease that is refractory to or relapsed <=12 months after the completion of first-line chemoimmunotherapy
Progressive disease (PD) as best response to first-line therapy
Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
Prior CAR T-cell therapy or glofitamab therapy.
History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring hospitalization and/or intravenous (IV) antimicrobials for management within 4 weeks of treatment initiation; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor.
History of uncontrolled human immunodeficiency virus (HIV) infection (HIV+ patients are not excluded from study if they have CD4 counts ≥ 200/µl, are on stable antiretroviral therapy for at least 1 month prior to study entry, and who have an undetectable viral load) or acute or chronic active hepatitis B or C infection; patients with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines.
Single group
Glofitamab
DrugGiven by IV
Obinutuzumab
DrugGiven by IV
Axi-cel
DrugGiven by IV
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
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M.D. Anderson Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
Kite, A Gilead Company
Collaborator
