r/r DLBCL, r/r MCL
Conditions
Interventions
RO7082859 (Glofitamab): Participants will receive intravenous (IV) glofitamab
Obinutuzumab: Participants will receive IV obinutuzumab
Gemcitabine hydrochloride: Participants will receive IV gemcitabin
Sponsors
Nanki Toshihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: DLBCL cohort -Histologically confirmed diffuse large B-cell lymphoma, NOS -At least one line of prior systemic therapy -Patients who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by ASCT by meeting the certain criteria -Eastern cooperative oncology group (ECOG) performance status of 0~2 -At least one bi-dimensionally measurable (>= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (>= 1 cm) extranodal lesion, as measured on CT scan, and at least one target FDG-avid lesion as measured on PET-CT scan -Adequate hematologic function -Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment -Adequate renal function MCL cohort -Histologically-confirmed MCL, demonstrating either overexpression of cyclin D1 (CCND1/BCL1), Cyclin D2 (CCND2), SOX11 or the presence of t(11:14) within 12 months of study entry -At least one line of prior systemic therapy, including in a BTK inhibitor and other systemic therapy (e.g., regimens containing CD20 monoclonal antibodies, chemotherapy, targeted therapies such as bortezomib, etc.) -At least one bi-dimensionally measurable (defined as >= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (>= 1 cm) extranodal lesion, as measured on CT scan -PET-positive disease at screening according to the Lugano Classification with at least one target FDG-avid lesion -Eastern cooperative oncology group (ECOG) performance status of 0~2 -Adequate hematologic function -Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment -Adequate renal function
Exclusion criteria
Exclusion criteria: DLBCL cohort -Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation -History of transformation of indolent disease to DLBCL (including FL 3b) -High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS -Primary mediastinal B-cell lymphoma -History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products -Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab -Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 -Prior treatment with GemOx -Treatment with radiotherapy, chemotherapy, immunotherapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment -Treatment with ASCT within 100 days prior to first study treatment -Treatment with CAR-T cell therapy within 30 days prior to first study treatment -Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma -Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease -Significant or extensive cardiovascular disease -Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) -Known history of progressive multifocal leukoencephalopathy -Prior allogeneic stem cell transplant MCL cohort -Leukemic, non-nodal MCL -History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products -Contraindication to obinutuzumab or tocilizumab -Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 -Prior treatment with CAR-T cell therapy -Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma -Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease -Significant or extensive cardiovascular disease -Known or suspected history of HLH -Known history of progressive multifocal leukoencephalopathy -Treatment with radiotherapy within 4 weeks prior to first study treatment -Treatment with ASCT within 100 days prior to first study treatment -Prior allogeneic stem cell transplant -Eligibility for stem cell transplantation (SCT). Participants achieving a CR during the course of the study should not intend to proceed to autologous hematopoietic stem cell transplant or allogeneic hematopoietic stem cell transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy, confirmatory Lugano 2014 Response Criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, efficacy, exploratory, phamacokinetics, phamacodynamics Lugano 2014 Response Criteria, NCI CTCAE v5.0, ASTCT CRS Grading system | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed