Testing Obinutuzumab with Glofitamab for b-cell non-hodgkins lymphoma

Exclusion

• −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
• −Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection
• −Prior enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085)
• −Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
• −Any history of Waldenstrom's macroglobulinemia
• −Primary mediastinal B-cell lymphoma
• −Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
• −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 the National Cancer Institute Common Terminology Criteria for Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (NCI CTCAE) v5.0 at enrollment
• −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
• −Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (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 protocolProtocolThe detailed plan a study must follow.Read more →
• −Significant or extensive cardiovascular disease
• −Significant pulmonary disease (including moderate or severe obstructive pulmonary disease)
• −Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →) within 4 weeks prior to the first study treatment
• −Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy
• −Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
• −Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
• −Prior solid organ transplantation or prior allogenic stem cell transplant
• −Active autoimmune disease requiring treatment
• −Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
• −Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency
• −Clinically significant history of cirrhotic liver disease
• −Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications
• −Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment
• −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
• −Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis