Recruiting

Phase 1

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

Sponsor:

Hoffmann-La Roche

Code:

NCT06624085

Conditions

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Glofitamab

Tocilizumab

Obinutuzumab

Gemcitabine

Oxaliplatin

Study Details

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

Study ID

NCT06624085

Start date

Apr 28, 2025

Status verified date

Sep, 2026

Completion date

Mar 22, 2027

Anticipated

Primary completion date

Mar 22, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Glofitamab

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

Tocilizumab

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

Obinutuzumab

Participants will receive IV obinutuzumab pretreatment

Gemcitabine

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

Oxaliplatin

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

Primary outcome measure

Incidence of Adverse Events (AEs) [ Time Frame: Up to 3 years ]
Complete response (CR) rate [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GO44900 https://forpatients.roche.com/ No attachments to email below.

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

Locations

Saddleback Memorial Medical Center

Recruiting

Laguna Hills, California, United States, 92653

Hoag Memorial Hospital

Recruiting

Newport Beach, California, United States, 92658

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

Recruiting

Santa Monica, California, United States, 90404-2023

AdventHealth Cancer Institute

Recruiting

Orlando, Florida, United States, 32804

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Kansas City VA Medical Center

Recruiting

Kansas City, Kansas, United States, 64128

Stony Brook Univ Cancer Ctr

Recruiting

Stony Brook, New York, United States, 11794

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Renovatio Clinical

Recruiting

The Woodlands, Texas, United States, 77380

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-08.