B Cell Lymphoma Clinical Trial
Official title:
A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma
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.
Primary Objectives - To evaluate the safety of axicabtagene ciloleucel (axi-cel) and glofitamab as combination therapy in 2nd line LBCL participants - To evaluate the effect of axi-cel and glofitamab as combination therapy on the best complete response rate in 2nd line LBCL participants Secondary Objectives - To evaluate the effect of axi-cel and glofitamab as combination therapy on overall survival (OS) in 2nd line LBCL participants - To evaluate the effect of axi-cel and glofitamab as combination therapy on progression free survival in 2nd line LBCL participants - To evaluate the effect of axi-cel and glofitamab as combination therapy on best overall response rate in 2nd line LBCL participants Exploratory Objectives - Characterization of tumors via tumor profiling and antigen density measurement using flow cytometry at baseline - Characterization of genetic markers via tumor single cell (sc) multiome sequencing and whole exome sequencing (WES) at baseline - To study the kinetics of circulating tumor DNA (ctDNA) during study progression - To evaluate the development of anti-axi-cel antibodies during study progression - To evaluate the effect of glofitamab administration on T cell exhaustion during study progression ;
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