Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma

Inclusion Criteria:

• Capability of understanding the purpose of the study and have given written informedconsent.

• Age greater than or equal to 18 years

• Histologically or cytologically confirmed relapsed or refractory MCL

• r/r MCL patients following standard first line chemotherapy who have received atleast one prior regimen including ibrutinib

• If the participant has received prior bendamustine, response duration must have been > 1 year

• Presence of at least one lymph node or mass measurable for response

• Life expectancy of at least 24 weeks

• ECOG 0-2

• Adequate hematological, renal and hepatic function unless inadequate function is dueto underlying disease

Exclusion Criteria:

• History of severe allergic or anaphylactic reactions to humanized or murinemonoclonal antibodies (MAbs or recombinant antibody-related fusion proteins) orknown sensitivity or allergy to bendamustine or rituximab

• Contraindications to polatuzumab, bendamustine or rituximab

• Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before cycle 1 day 1

• Use of any investigational agent within 28 days prior to initiation of studytreatment

• History of malignancy other than squamous cell carcinoma, basal cell carcinoma ofthe skin or carcinoma in situ of the cervix within the last 3 years

• Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy,or any investigational agent for the purposes of treating cancer within 2 weeksprior to cycle 1 day

• Major surgery or significant traumatic injury within 28 days of the first dose ofstudy drug

• Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposesother than lymphoma symptom control

• Autologous stem cell transplant (SCT) within 100 days prior to cycle 1 day 1

• Prior allogeneic SCT

• Eligibility for autologous SCT

• Primary or secondary CNS lymphoma

• Current grade >1 peripheral neuropathy

• Evidence of significant, uncontrolled concomitant diseases that could affectcompliance with the protocol or interpretation of results, including significantcardiovascular disease (such as New York Heart Association Class III or IV cardiacdisease, myocardial infarction within the last 6 months, unstable arrhythmias, orunstable angina) or significant pulmonary disease (including obstructive pulmonarydisease and history of bronchospasm)

• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episodeof infection requiring treatment with IV antibiotics or hospitalization within 4weeks prior to Cycle 1 Day 1

• Suspected or latent tuberculosis

• Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitisC virus (HCV) antibody

• Known history of human immunodeficiency virus (HIV) seropositive status or knowninfection with human T-cell leukemia virus 1 (HTLV-1) virus

• Women who are pregnant or lactating or who intend to become pregnant within a yearof the last dose of study treatment. Women of childbearing potential must have anegative pregnancy test at screening, pregnancy testing must be performed within 7days before first administration of IMP. Approved methods of birth control must beused

• Women of childbearing potential, including women whose last menstrual period wasless than one year prior to screening, unable or unwilling to use adequatecontraception from study start to the last dose of protocol therapy. Adequatecontraception defined as hormonal birth control, intrauterine device, double barriermethod or total abstinence.

• Male subjects unable or unwilling to use adequate contraception methods.

• Evidence of laboratory abnormalities in standard renal, hepatic, or coagulationfunction tests