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

Running, not enrolling · Phase 1

Conditions studied: Lymphoma

In brief

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).

Key facts

Study ID

NCT06624085

Run by

Hoffmann-La Roche

People needed

50

Starts

2025-04-28

Expected to finish

2027-03-22

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• University of California Los Angeles (UCLA) - Cancer Care - Santa Monica — Santa Monica, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• AdventHealth Cancer Institute — Orlando, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• University of Illinois Cancer Center — Chicago, Illinois, United States
• Kansas City VA Medical Center — Kansas City, Kansas, United States
• Christus Health - Christus St. Vincent Regional Medical Center — Santa Fe, New Mexico, United States
• Stony Brook Univ Cancer Ctr — Stony Brook, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Renovatio Clinical - El Paso — El Paso, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Renovatio Clinical — The Woodlands, Texas, United States
• Auxilio Mutuo Cancer Center — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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