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New hope for lymphoma patients: drug combo trial aims to shrink tumors

NCT ID NCT06624085

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This early-phase study tests a new drug (glofitamab) combined with two chemotherapy drugs (gemcitabine and oxaliplatin) in about 50 U.S. adults whose diffuse large B-cell lymphoma has returned or stopped responding to prior treatment. The main goals are to check safety and see how many patients achieve complete remission. The study also includes people from racial and ethnic groups often underrepresented in research.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lymphoma relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Cancer Institute

    RECRUITING

    Orlando, Florida, 32804, United States

  • Auxilio Mutuo Cancer Center

    RECRUITING

    San Juan, 00917, Puerto Rico

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Christus Health - Christus St. Vincent Regional Medical Center

    WITHDRAWN

    Santa Fe, New Mexico, 87505, United States

  • East Carolina University

    WITHDRAWN

    Greenville, North Carolina, 27834, United States

  • Georgetown University

    WITHDRAWN

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

  • Hoag Memorial Hospital

    RECRUITING

    Newport Beach, California, 92658, United States

  • Kansas City VA Medical Center

    RECRUITING

    Kansas City, Kansas, 64128, United States

  • Renovatio Clinical

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Renovatio Clinical - El Paso

    WITHDRAWN

    El Paso, Texas, 79915, United States

  • Saddleback Memorial Medical Center

    RECRUITING

    Laguna Hills, California, 92653, United States

  • Stony Brook Univ Cancer Ctr

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    WITHDRAWN

    La Jolla, California, 92093, United States

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

    RECRUITING

    Santa Monica, California, 90404-2023, United States

  • University of Illinois Cancer Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Walter Reed National Military Medical Center

    WITHDRAWN

    Bethesda, Maryland, 20814, United States

  • Winship Cancer Institute of Emory University

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30329, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.