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
- Conditions
- Relapsed/refractory B-cell non-Hodgkin’s lymphoma (r/r NHL)MedDRA version: 25.0Level: LLTClassification code: 10086815Term: B-cell non-Hodgkin´s lymphoma recurrent Class: 100000004848MedDRA version: 25.0Level: LLTClassification code: 10086816Term: B-cell non-Hodgkin´s lymphoma refractory Class: 100000004848Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505625-14-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 576
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
Inability to comply with protocol mandated hospitalization and restrictions, Patients with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma, Patients with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH), 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, Pregnant, breast-feeding or intending to become pregnant during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method