A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest diameter
Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
Adequate hematologic function
Participants must also meet the following criteria for study entry into the Phase Ib portion:
Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen
Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy
Treatment with at least one prior CD20-directed therapy
Group B only: no prior treatment with polatuzumab vedotin
Participants must also meet the following criteria for study entry in the Phase II portion:
Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
International Prognostic Index (IPI) score of 2-5
You may not be if
Prior treatment with mosunetuzumab
Prior allogenic stem-cell transplant
Current Grade \>1 peripheral neuropathy
Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
Prior solid organ transplantation
History of autoimmune disease
Current or past history of central nervous system (CNS) lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Significant cardiovascular disease or pulmonary disease
Clinically significant history of liver disease
Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis
Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion:
Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1
Prior treatment with radiotherapy within 2 weeks prior to C1D1
Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia)
Prior treatment with \>250 mg/m\^2 doxorubicin (or equivalent anthracycline dose)
Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion:
Participants with transformed lymphoma
Prior therapy for B-cell NHL
Clareo Health | A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
