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Phase 2 Study of Glofitamab with Chemotherapy for B-Cell Lymphoma

This study is looking at a new way to give glofitamab, a drug that targets cancer cells, along with chemotherapy drugs gemcitabine and oxaliplatin, for people with aggressive B-cell Non-Hodgkin's lymphoma that has come back or not responded to previous treatment (relapsed/refractory). The main goal is to see if a special plan for giving these medicines can reduce a side effect called cytokine release syndrome (CRS), which is an immune reaction. You would receive obinutuzumab first, then glofitamab with gemcitabine and oxaliplatin. The study aims to make this treatment possible in an outpatient setting. About 100 people are expected to join this study.

Study design
This is a Phase II interventional study involving approximately 100 participants. It is designed to evaluate a specific treatment approach.
What's involved
You would receive intravenous (IV) obinutuzumab, followed by IV glofitamab, gemcitabine, and oxaliplatin for up to 12 cycles (21 days each) for glofitamab, and up to 8 cycles for gemcitabine and oxaliplatin.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for the incidence of cytokine release syndrome (CRS) for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06806033

Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL

Recruiting
PHASE2Ages 18+InterventionalTreatment
Hoffmann-La Roche
~130 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:ObinutuzumabGlofitamabGemcitabineOxaliplatin

At a glance

Recruiting sites
41 of 53 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Cytokine Release Syndrome (CRS)
Measured over Up to approximately 5 years

Conditions

Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaHigh Grade B-Cell Lymphoma

NCT06806033

Where you'd take part

This study runs at 53 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaskano site contact published

    Recruiting

  • Arthur J.E. Child Comprehensive Cancer Center

    Calgary, Alberta, Canadano site contact published

    Recruiting

  • Baylor Scott & White Health

    Temple, Texasno site contact published

    Recruiting

  • Boston Medical Center

    Boston, Massachusettsno site contact published

    Recruiting

  • Cancer Care Specialists of Central Illinois

    Swansea, Illinoisno site contact published

    Recruiting

  • CancerCare Manitoba (CCMB)

    Winnipeg, Manitoba, Canadano site contact published

    Recruiting

  • CHU de Bordeaux

    Pessac, Franceno site contact published

    Recruiting

  • CHU de Grenoble

    La Tronche, Franceno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: GO45434 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Eligibility criteria

Inclusion

Life expectancy \>= 12 weeks.
For participants in the Glofit-GemOx combination therapy cohort (Cohort A) and the glofitamab monotherapy cohort (Cohort B), participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma (FL); participants with transformed FL must be relapsed or refractory (R/R) to standard therapies of transformed FL) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022). A fresh biopsy at study entry is not mandated. The histology can be confirmed based on fresh biopsy, or pathology report from a previous biopsy or an assessment of archival tumor tissue.
R/R disease, defined as: relapsed = disease that has recurred following a response that lasted \>/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy.
At least one line of prior systemic therapy.
Participants who have failed one prior line of therapy (eligible to Cohort A) must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant.
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) status of 0, 1, or 2.
According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting.

Exclusion

Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085).
Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation.
Any history of Waldenstrom's macroglobulinemia.
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.
Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab. For participants in the monotherapy cohort (Cohort B), participants with contraindication to obinutuzumab or tocilizumab will be excluded.
Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.
For the Glofit-GemOx combination therapy cohort (Cohort A), prior treatment with gemcitabine or oxaliplatin.
For the Glofit-GemOx combination therapy cohort (Cohort A), peripheral neuropathy or paresthesia assessed to be Grade \>= 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrolment.
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.
Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (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.
Significant pulmonary disease (including moderate or severe obstructive pulmonary disease).
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 (as evaluated by the investigator) within 4 weeks prior to the first study treatment.
Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection.
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy.
Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia).
Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study.
Prior solid organ transplantation or prior allogenic stem cell transplant.
Active autoimmune disease requiring treatment.
Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment.
Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant 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.
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications.
Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment.

What this trial measures

  • Incidence of Cytokine Release Syndrome (CRS)Up to approximately 5 years