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New combo aims to tame side effects in Tough-to-Treat lymphoma

NCT ID NCT06806033

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 4 times

Summary

This study tests a new drug combination (glofitamab plus gemcitabine and oxaliplatin) in about 100 people with aggressive B-cell lymphoma that has returned or not responded to prior therapy. The main goal is to see if a better steroid plan can reduce a serious side effect called cytokine release syndrome, making it safer to give the treatment without needing a hospital stay.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

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

Started

Mar 2025

Expected to finish

Mar 2029

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: * 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. 1. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS). 2. High-Grade B-Cell Lymphoma (HGBL), NOS. 3. DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (BCL2) rearrangements. * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell non-Hodgkin lymphoma cytokine release syndrome diffuse large B-cell lymphoma high grade B-cell lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement high-grade B-cell lymphoma double-hit/triple-hit non-Hodgkin lymphoma Recurrence relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

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

B-cell non-hodgkins lymphoma Diffuse large B cell lymphoma Relapsed or refractory aggressive B-cell non-hodgkins lymphoma

How to take part

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

  1. The places running it

    41 sites in 4 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

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    ACTIVE_NOT_RECRUITING

    Brescia, Lombardy, 25123, Italy

  • Alaska Oncology & Hematology, LLC

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Arthur J.E. Child Comprehensive Cancer Center

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 05505, South Korea

  • Baylor Scott & White Health

    RECRUITING

    Temple, Texas, 76502, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie

    WITHDRAWN

    Berlin, 12200, Germany

  • CHU DE RENNES - CHU Pontchaillou

    WITHDRAWN

    Rennes, 35033, France

  • CHU de Bordeaux

    RECRUITING

    Pessac, 33600, France

  • CHU de Grenoble

    RECRUITING

    La Tronche, 38700, France

  • Cancer Care Specialists of Central Illinois

    RECRUITING

    Swansea, Illinois, 62226, United States

  • CancerCare Manitoba (CCMB)

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    WITHDRAWN

    Berlin, 13353, Germany

  • Chu De Tours

    RECRUITING

    Tours, 37000, France

  • Chu de Montpellier-St Eloi

    RECRUITING

    Montpellier, 34295, France

  • Community Cancer Institute (CCI)

    RECRUITING

    Clovis, California, 93611, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Epworth Hospital

    ACTIVE_NOT_RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • Hematology Oncology Associates of Central New York

    RECRUITING

    East Syracuse, New York, 13057, United States

  • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

    ACTIVE_NOT_RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • Irccs Istituto Europeo Di Oncologia (IEO)

    ACTIVE_NOT_RECRUITING

    Milan, Lombardy, 20141, Italy

  • Istituto Clinico Humanitas

    ACTIVE_NOT_RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale

    ACTIVE_NOT_RECRUITING

    Naples, Campania, 80131, Italy

  • Los Angeles Cancer Network

    RECRUITING

    Glendale, California, 91204, United States

  • Mary Bird Perkins Cancer Ctr

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Mission Blood and Cancer - MercyOne Cancer Center

    RECRUITING

    Waukee, Iowa, 50263, United States

  • Mount Sinai Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33140, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • New York Oncology Hematology, P.C.

    RECRUITING

    Albany, New York, 12206, United States

  • North Florida/ South Georgia VA Medical Center

    RECRUITING

    Gainesville, Florida, 32608, United States

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Oncology Associates of Oregon, P.C

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Orlando Health Cancer Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Otto von Guericke Uni Magdeburg Uniklinik

    RECRUITING

    Magdeburg, 39120, Germany

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

  • Providence St. Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

  • Rocky Mountain Cancer Centers, LLP

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Seoul National University Bundang Hospital

    ACTIVE_NOT_RECRUITING

    Seongnam-si, 463-707, South Korea

  • Seoul National University Hospital

    WITHDRAWN

    Seoul, 03080, South Korea

  • St Luke?s Cancer Institute

    RECRUITING

    Boise, Idaho, 83712, United States

  • Tennessee Oncology

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Texas Oncology- Northeast Texas

    RECRUITING

    Tyler, Texas, 75702, United States

  • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

    RECRUITING

    Torrance, California, 90502-2006, United States

  • University of Kentucky - Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, 50937, Germany

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Panorama City, California, 91402, United States

  • Virginia Cancer Specialists, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates - Virginia Beach

    RECRUITING

    Virginia Beach, Virginia, 23456, United States

  • Zuckerberg San Francisco General Hospital

    RECRUITING

    San Francisco, California, 94110, United States

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