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AzTrials

LymphomaPhase 1NCT06624085

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 1 study testing Glofitamab, Tocilizumab and Obinutuzumab in people with Lymphoma, run by Hoffmann-La Roche at 9 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Glofitamab, Tocilizumab and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
9 sitesin 2 countries
Study dates
28 Apr 2025to 22 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States8 sites

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Kansas City VA Medical Center

    Kansas City, Kansas, 64128

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

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

    Santa Monica, California, 90404-2023

  • Stony Brook Univ Cancer Ctr

    Stony Brook, New York, 11794

  • Renovatio Clinical

    The Woodlands, Texas, 77380

Other trials in United States

Puerto Rico1 site

  • Auxilio Mutuo Cancer Center

    San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: 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).

Conditions
Lymphoma
Being tested
Glofitamab, Tocilizumab, Obinutuzumab, Gemcitabine, Oxaliplatin
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

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

  • TocilizumabDrug

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

  • ObinutuzumabDrug

    Participants will receive IV obinutuzumab pretreatment

  • GemcitabineDrug

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

  • OxaliplatinDrug

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

Study groups in NCT06624085
Study groupRoleWhat they receive
Gemcitabine + Glofitamab + OxaliplatinExperimentalParticipants 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).
Receives: Drug: Glofitamab; Drug: Tocilizumab; Drug: Obinutuzumab; Drug: Gemcitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Measured: Up to 3 years

  2. Complete response (CR) rate

    Measured: Up to 3 years

Secondary outcomes (7)

  1. Objective response rate (ORR)

    Measured: Up to 3 years

  2. Duration of response (DOR)

    Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 3 years)

  3. Duration of CR

    Measured: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to 3 years)

  4. Progression-free survival (PFS)

    Measured: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 3 years)

  5. Overall Survival (OS)

    Measured: From enrollment to date of death from any cause (up to 3 years)

  6. Serum concentration of glofitamab

    Measured: Up to 3 years

  7. Incidence of anti-drug antibodies to glofitamab

    Measured: Baseline up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start28 Apr 2025
  3. Primary completion22 Mar 2027 (estimated)
  4. Study completion22 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06624085
Sponsor's protocol ID
GO44900
Status last verified
Oct 2026
First submitted
1 Oct 2024
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Glofitamab, Tocilizumab and Obinutuzumab in people with Lymphoma, run by Hoffmann-La Roche at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06624085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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