B-cell non-Hodgkin's lymphoma, follicular lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : RO7030816
INN of investigational material : Mosunetuzumab
Therapeutic category code : 429 Other antitumor agents
Brand name : Lunsumio for Intravenous In
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Dose-escalation cohorts] - Histologically documented CD20+ B-cell NHL. - Patients with r/r B-cell NHL and no other standard therapy(standard chemotherapy, autologous hematopoietic stem cell transplantation, etc.) that should be prioritized. - ECOG PS of 0 or 1. - Life expectancy more than 12 weeks from the date of enrollment. - Major organ function meets all criteria. [Expansion cohort] - Histologically documented CD20+ Grade 1-3a relapsed or refractory FL. - Patient received at least two prior systemic lymphoma therapy includinganti-CD20 targeted therapies and alkylating agents. - ECOG PS of 0 or 1. - Life expectancy more than 12 weeks from the date of enrollment. - Major organ function meets all criteria. [2L+ FL SC cohort] - Histologically documented CD20+ Grade 1-3a relapsed or refractory FL. - Patient received at least one prior systemic lymphoma therapy. - ECOG PS of 0 to 2. - Life expectancy more than 12 weeks from the date of enrollment. - Major organ function meets all criteria. - Previously untreated patients with FL must require systemic therapy assessed by investigator based on Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria. [3L+ FL SC cohort] - Histologically documented CD20+ Grade 1-3a relapsed or refractory FL. - Patient received at least two prior systemic lymphoma therapy includinganti-CD20 targeted therapies and alkylating agents. - ECOG PS of 0 to 2. - Life expectancy more than 12 weeks from the date of enrollment. - Major organ function meets all criteria.
Exclusion criteria
Exclusion criteria: [Dose-escalation cohorts, expansion cohort, 3L+ FL SC cohort] - Pregnant or lactating woman. - Current or previous autoimmune disease. - Positive test result for human immunodeficiency virus antibody,hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody. - Current or previous clinically significant liver disease. - Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases. - History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation. - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins. [2L+ FL SC cohort] - Pregnant or lactating woman. - Current or previous autoimmune disease. - Positive test result for human immunodeficiency virus antibody,hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody. - Current or previous clinically significant liver disease. - Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases. - History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation. - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins. - Patients at risk of hypersensitivity to lenalidomide and to excipients of lenalidomide - Documented refractoriness to lenalidomide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other NCI CTCAE, DLT, Revised Response Criteria for Malignant Lymphoma, Lugano response criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics other Revised Response Criteria for Malignant Lymphoma, Lugano response criteria, Endpoints other (ADA) | — |
Countries
Japan
Outcome results
None listed