Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Treatment for Relapsed or Refractory Large B Cell Lymphoma

What this Trial Is About

Researchers are evaluating the combination of axicabtagene ciloleucel axi-cel and glofitamab as a first-line treatment for high-risk large B cell lymphoma LBCL patients or as a second-line treatment for LBCL patients whose disease has relapsed or is refractory. The study aims to assess the safety and effect of this combination therapy on response rates, overall survival, and progression-free survival in these patients. Additionally, the study will explore tumor characteristics and immune responses during treatment. Participants will receive axicabtagene ciloleucel and glofitamab intravenously, with glofitamab given according to a step-up dosing schedule. The study focuses on second-line LBCL patients who have relapsed or are refractory to previous therapies. The treatment includes premedication with obinutuzumab and involves hospitalization at the time of the first dose of glofitamab. Participants must meet specific health criteria to ensure they can safely receive the study drugs. During the study, participants will be monitored for safety and adverse events for about one year. Assessments include tumor profiling, genetic testing, and tracking circulating tumor DNA and immune markers over time. Participants will have laboratory tests, clinical evaluations, and follow-up visits as part of the protocol. The research team will measure treatment response and overall survival to understand the impact of this combination therapy in LBCL patients.

A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma