A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

• * Histologically confirmed DLBCL, not otherwise specified (NOS)
• * Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy) disease
• * At least one prior line of systemic therapy
• * Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
• * At least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\> 1 cm) extranodal lesion, as measured on CT scan
• * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• * Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
• * Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
• * History of transformation of indolent disease to DLBCL
• * High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
• * Primary mediastinal B-cell lymphoma
• * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
• * Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
• * Prior treatment with gemcitabine or oxaliplatin
• * Peripheral neuropathy or paresthesia assessed to be Grade \>/= 2 according to NCI CTCAE v5.0 at enrollment
• * Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
• * Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
• * Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
• * Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible
• * Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• * History of other primary malignancy, with exceptions defined by the protocol
• * Significant or extensive cardiovascular disease, or significant pulmonary disease
• * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
• * Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment
• * Suspected or latent tuberculosis
• * Positive test results for hepatitis B (HBV) or hepatitis C (HCV)
• * Known or suspected chronic active Epstein-Barr viral infection
• * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
• * Known history of progressive multifocal leukoencephalopathy
• * Prior solid organ transplantation
• * Prior allogenic stem cell transplant
• * Active autoimmune disease requiring treatment
• * Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment
• * Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency
• * Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
• * Clinically significant history of cirrhotic liver disease