A Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination with Obinutuzumab, Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

Trial details

Who runs it

F. Hoffmann-La Roche AG

Trial code

EU 2023-505625-14-00

Record updated

2026. november 6.

Original description

To determine:  the maximal tolerated dose or optimal biologic dose and dose-limiting toxicity of glofitamab as single agent and in combination with obinutuzumab following Gpt in patients with r/r NHL  a recommended dose and schedule of glofitamab as single agent and in combination with obinutuzumab following Gpt To evaluate:  The safety, tolerability, and pharmacokinetic (PK) of glofitamab as single agent and in combination with obinutuzumab following obinutuzumab pretreatment (Gpt) in patients with r/r (CD)20 + B-cell NHL  The efficacy of glofitamab as single agent following Gpt in patients in patients with Diffuse large B-cell lymphoma, and in patients with r/r Follicular lymphoma (FL) measured by Independent Review Committee (IRC)-assessed complete response rate (CRR) according to Lugano 2014 Classification  To evaluate the efficacy of glofitamab as single agent following Gpt and/or dGpt in R/R MCL patients by IRC-assessed CRR according to Lugano ClassificationRead full original descriptionShow less

A Multicenter, Open-Label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination with Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

To determine:  the maximal tolerated dose or optimal biologic dose and dose-limiting toxicity of glofitamab as single agent and in combination with obinutuzumab following Gpt in patients with r/r NHL  a recommended dose and schedule of glofitamab as single agent and in combination with obinutuzumab following Gpt To evaluate:  The safety, tolerability, and pharmacokinetic (PK) of glofitamab as single agent and in combination with obinutuzumab following obinutuzumab pretreatment (Gpt) in patients with r/r (CD)20 + B-cell NHL  The efficacy of glofitamab as single agent following Gpt in patients in patients with Diffuse large B-cell lymphoma, and in patients with r/r Follicular lymphoma (FL) measured by Independent Review Committee (IRC)-assessed complete response rate (CRR) according to Lugano 2014 Classification  To evaluate the efficacy of glofitamab as single agent following Gpt and/or dGpt in R/R MCL patients by IRC-assessed CRR according to Lugano Classification

Inclusion: Patient willing and able to comply with protocol-mandated hospitalizations upon administration of glofitamab and also all study-related procedures, in Part III, this includes completion of Patient-reported outcome; For Parts I and II:Grades 1-3b FL; Marginal zone lymphoma; Mantle cell lymphoma; DLBCL; Primary mediastinal B-cell lymphoma; Richter’s transformation; and transformed FL (trFL) For Part III expansion cohorts: DLBCL cohort (r/r DLBCL, not otherwise specified [NOS]/high-grade B-cell lymphoma [HGBCL],PMBCL and trFL). Patients must have relapsed after or failed to respond to at least two prior systemic treatment regimens (including at least one prior regimen containing anthracycline, and at least one containing an anti CD20-directed therapy). cohort: R/R FL cohort: Grades 1-3a FL patients must have relapsed after or failed to respond to at least two prior lines of systemic therapy and must have received prior treatment with rituximab and alkylating agents; For Part III expansion cohorts: Life expectancy (in the opinion of the Investigator) of >= 12 weeks; Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as >1.0 cm in its longest dimension; Eastern Cooperative Oncology Group performance status of 0 or 1; Adequate liver, hematological, and renal function.

Exclusion: Patients with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to Gpt infusion or by clinical judgment in the absence of a positive blood culture; Patients with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing  A severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) or antigen test within 7 days prior to enrollment is recommended; Patients with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH); Inability to comply with protocol mandated hospitalization and restrictions; Patients with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma; Pregnant, breast-feeding or intending to become pregnant during the study.

EU CTIS 2023-505625-14-00