Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy

PRIMARY OBJECTIVE: I. To assess anti-tumor activity of odronextamab + CAR T-cell therapy in in patients with relapsed or refractory (R/R) DLBCL. SECONDARY OBJECTIVES: I. To evaluate the toxicities of odronextamab + CAR T-cell therapy in patients with R/R DLBCL. II. To further assess anti-tumor activity of odronextamab + CAR T-cell therapy in patients with R/R DLBCL. OUTLINE: Patients receive odronextamab intravenously (IV) over 1-4 hours on days 1, 2, 8, 9, 15, and 16 of cycle 1, on days 1, 8, and 15 of cycles 2-4 then on days 1 and 15 of subsequent cycles until achievement of durable complete response (CR). Cycles repeat every 21 days in the absence of durable CR, disease progression, or unacceptable toxicity. Patients with durable CR for ≥ 9 months may then receive odronextamab IV over 1-4 hours on day 1 of each subsequent cycle. These cycles repeat every 28 days for up to a total of 2 years in the absence of disease progression or unacceptable toxicity. Patients receive SOC CAR T-cell therapy if disease assessment shows less than a CR after cycle 4, or after cycle 5 if disease assessment shows progressive disease (PD) any time after cycle 5. Additionally, patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and blood sample collection, positron emission tomography (PET)/computed tomography (CT) or CT throughout the study. Patients may also undergo CT of the brain at screening. After completion of study treatment, patients are followed up at 30 days then every 4 months for up to 2 years.