A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Study Overview

• Status: Recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Drug: Tocilizumab; Drug: Glofitamab; Drug: Obinutuzumab; Drug: Gemcitabine; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: GO44900 https://forpatients.roche.com/; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com
• Study Contact Backup: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Recruiting
    • Auxilio Mutuo Cancer Center
• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • UC San Diego Moores Cancer Center
    • Laguna Hills, California, United States, 92653
      • Recruiting
      • Saddleback Memorial Medical Center
    • Santa Monica, California, United States, 90404-2023
      • Recruiting
      • University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Recruiting
      • Georgetown University
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Cancer Institute
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Winship Cancer Institute of Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Cancer Center
  • Kansas
    • Kansas City, Kansas, United States, 64128
      • Recruiting
      • Kansas City VA Medical Center
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Recruiting
      • Walter Reed National Military Medical Center
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Recruiting
      • Christus Health - Christus St. Vincent Regional Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook Univ Cancer Ctr
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • East Carolina University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
  • Texas
    • El Paso, Texas, United States, 79915
      • Recruiting
      • Renovatio Clinical - El Paso
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • Renovatio Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed DLBCL, not otherwise specified (NOS)
• Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed < 6 months after completion of the last line of therapy) disease
• At least one prior line of systemic therapy
• Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Exclusion Criteria:

• Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
• Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
• History of transformation of indolent disease to DLBCL
• High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
• Primary mediastinal B-cell lymphoma
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
• Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
• Prior treatment with gemcitabine or oxaliplatin
• Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to NCI CTCAE v5.0 at enrollment
• Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
• Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
• Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
• Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible
• Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• History of other primary malignancy, with exceptions defined by the protocol
• Significant or extensive cardiovascular disease, or significant pulmonary disease
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
• Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment
• Suspected or latent tuberculosis
• Positive test results for hepatitis B (HBV) or hepatitis C (HCV)
• Known or suspected chronic active Epstein-Barr viral infection
• Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
• Known history of progressive multifocal leukoencephalopathy
• Prior solid organ transplantation
• Prior allogenic stem cell transplant
• Active autoimmune disease requiring treatment
• Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment
• Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency
• Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
• Clinically significant history of cirrhotic liver disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Gemcitabine + Glofitamab + Oxaliplatin; Participants will receive a single dose of intravenous (IV) obinutuzumab pretreatment 7 days prior to the first dose of glofitamab, followed by up to 8 cycles of glofitamab + gemcitabine + oxaliplatin. This will be followed by up to 4 cycles of glofitamab monotherapy, for a total of up to 12 cycles of glofitamab (cycle length = 21 days).

Drug: Tocilizumab; Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS); Drug: Glofitamab; Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days); Drug: Obinutuzumab; Participants will receive IV obinutuzumab pretreatment; Drug: Gemcitabine; Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days); Drug: Oxaliplatin; Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Up to 3 years
Complete response (CR) rate	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	Up to 3 years
Duration of response (DOR)	From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 3 years)
Duration of CR	From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to 3 years)
Progression-free survival (PFS)	From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 3 years)
Overall Survival (OS)	From enrollment to date of death from any cause (up to 3 years)
Serum concentration of glofitamab	Up to 3 years
Incidence of anti-drug antibodies to glofitamab	Baseline up to 3 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemic and Lymphatic Diseases; Lymphoma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Oxaliplatin; Gemcitabine; tocilizumab; obinutuzumab; glofitamab
• Other Study ID Numbers: GO44900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No