A Phase III, Open-Label, Multicenter, Randomized Study Evaluating Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma.

Inclusion Criteria

- Life expectancy at least 12 weeks

- Histologically-confirmed MCL, with documentation of either overexpression of cyclin

D1 or the presence of t(11:14)

- Relapsed (disease progression after the last treatment regimen) or refractory

(failure to achieve a partial or complete response from the last treatment regimen)

disease

- At least 1 line of prior systemic therapy including a BTK inhibitor and additional

systemic therapy option

- Confirmed availability of tumor tissue, unless deemed unsafe per investigator

assessment

- At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion,

or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on

CT scan

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Negative HIV test at screening

- Adequate hematological function

Exclusion Criteria

- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or

within 3 months after the final dose of tocilizumab, 2 months after the final dose

of glofitamab, whichever is longer

- Leukemic, non-nodal MCL

- 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

- Contraindication to obinutuzumab or rituximab, and either bendamustine or

lenalidomide

- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20

and CD3

- Prior treatment with CAR-T cell therapy

- Treatment with systemic therapy or BTK inhibitors, or any investigational agent for

the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is

shorter) prior to first study treatment

- Primary or secondary CNS lymphoma at the time of recruitment or history of CNS

lymphoma

- Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or

neurodegenerative disease

- History of other malignancy that could affect compliance with the protocol or

interpretation of results

- Significant or extensive cardiovascular disease

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection

at study enrollment or any major episode of infection within 4 weeks prior to the

first study treatment

- Suspected or latent tuberculosis

- Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)

- Known or suspected chronic active Epstein-Barr viral infection (EBV)

- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)

- Known history of progressive multifocal leukoencephalopathy (PML)

- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or

better

- 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 allogenic stem cell transplant

- Eligibility for stem cell transplantation (SCT)

- Active autoimmune disease requiring treatment

- Prior treatment with systemic immunosuppressive medications within 2 weeks or five

half-lives (whichever is shorter) prior to the first dose of study treatment

- Corticosteroid therapy within 2 weeks prior to first dose of study treatment

- Recent major surgery (within 4 weeks before the first study treatment) other than

for diagnosis

- Clinically significant history of cirrhotic liver disease