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

NCT06624085 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GO44900
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 17

Brief Summary

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).

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events (AEs)

  Up to 3 years

• Complete response (CR) rate

  Up to 3 years

Secondary Outcomes (7)

• 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)

Study Arms (1)

Gemcitabine + Glofitamab + Oxaliplatin

EXPERIMENTAL

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: Glofitamab; Drug: Tocilizumab; Drug: Obinutuzumab; Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

Gemcitabine DRUG

Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)

Gemcitabine + Glofitamab + Oxaliplatin

Oxaliplatin DRUG

Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)

Gemcitabine + Glofitamab + Oxaliplatin

Glofitamab DRUG

Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)

Gemcitabine + Glofitamab + Oxaliplatin

Tocilizumab DRUG

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

Gemcitabine + Glofitamab + Oxaliplatin

Obinutuzumab DRUG

Participants will receive IV obinutuzumab pretreatment

Gemcitabine + Glofitamab + Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

RECRUITING

University of California Los Angeles (UCLA) - Cancer Care - Santa Monica

Santa Monica, California, 90404-2023, United States

RECRUITING

Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

AdventHealth Cancer Institute

Orlando, Florida, 32804, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

Kansas City VA Medical Center

Kansas City, Kansas, 64128, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

RECRUITING

Christus Health - Christus St. Vincent Regional Medical Center

Santa Fe, New Mexico, 87505, United States

RECRUITING

Stony Brook Univ Cancer Ctr

Stony Brook, New York, 11794, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Renovatio Clinical - El Paso

El Paso, Texas, 79915, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Renovatio Clinical

The Woodlands, Texas, 77380, United States

RECRUITING

Auxilio Mutuo Cancer Center

San Juan, 00917, Puerto Rico

RECRUITING

Related 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.

MeSH Terms

Conditions

Lymphoma

Interventions

glofitamab; tocilizumab; obinutuzumab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GO44900 https://forpatients.roche.com/

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 2, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (16)