A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT ID: NCT04657302

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2024-01-12

Brief Summary

This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R/R DLBCL

Participants will receive a fixed dose of obinutuzumab pre-treatment followed by glofitamab on Cycle 1 Days 8 and 15, then every 3 weeks (Q3W) from Cycles 2-12 (cycle length = 21 days).

Group Type: EXPERIMENTAL

Obinutuzumab

Intervention Type: DRUG

Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.

Glofitamab

Intervention Type: DRUG

Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).

Tocilizumab

Intervention Type: DRUG

Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).

Interventions

Obinutuzumab

Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.

Intervention Type: DRUG

Glofitamab

Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).

Intervention Type: DRUG

Tocilizumab

Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically-confirmed DLBCL
• Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (including at least one prior regimen containing anthracycline, and at least one containing an anti-CD20-directed therapy)
• Participants must have measurable disease: 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 (ECOG) Performance Status of 1 or 1
• Adverse events from prior anti-cancer therapy must have resolved to Grade </=1
• Adequate liver, hematological, and renal function
• Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential
• Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol, and agree to refrain from donating eggs during the treatment period and for at least 18 months after the final dose of obinutuzumab, 2 months after the final dose of glofitamab, and 3 months after the final dose of tocilizumab (if applicable)
• Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol, and agree to refrain from donating sperm during the treatment period and for at least 3 months after the final dose of obinutuzumab, 4 months after the final dose of glofitamab, and 2 months after the final dose of tocilizumab (if applicable)
• Reside in the People's Republic of China

Exclusion Criteria

• Richter's transformation
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to first study treatment
• Suspected or latent tuberculosis
• Positive for HIV, hepatitis C (HCV), or hepatitis B (HBV)
• Known or suspected chronic active Epstein-Barr virus infection
• Known or suspected history of hemaphagocytic lymphohistiocytosis (HLH)
• Prior treatment with systemic immunotherapeutic agents
• History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents
• Documented refractoriness to an obinutuzumab monotherapy-containing regimen
• Treatment with standard radiotherapy, any chemotherapeutic agent, including CAR T therapy
• Prior solid organ or allogenic stem cell transplantation
• Autologous stem cell transplantation within 100 days prior to obinutuzumab infusion
• Active autoimmune disease requiring treatment
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
• History of confirmed progressive multifocal leukoencephalopathy (PML)
• Current or past history of CNS lymphoma
• Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
• Major surgery or significant traumatic injury < 28 days prior to obinutuzumab infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
• Another invasive malignancy in the last 2 years
• Significant cardiovascular disease
• Administration of a live, attenuated vaccine within 4 weeks before obinutizumab infusion, or anticipation that one will be required during the study
• Systemic immunosuppresive medications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beijing Cancer Hospital

Beijing, , China

Peking University Third Hospital

Beijing, , China

Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

Guangzhou, , China

Harbin Medical University Cancer Hospital

Harbin, , China

Jiangsu Province Hospital

Nanjing, , China

Tianjin Cancer Hospital

Tianjin, , China

Countries

China

Other Identifiers

YO42610

Identifier Type: -

Identifier Source: org_study_id