New drug combo shows promise for Hard-to-Treat lymphoma

NCT ID NCT03075696

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

First seen Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tests a new drug called glofitamab, given alone or with obinutuzumab, in people with B-cell non-Hodgkin's lymphoma that has come back or not responded to prior treatments. The trial has three parts to find the best dose and check safety and effectiveness. About 940 participants are expected to take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: glofitamab (a type of immunotherapy) given with obinutuzumab
What this could lead to: If successful, this could offer a new treatment option for people with B-cell non-Hodgkin's lymphoma that has not responded to other therapies.
What could go wrong: This is an early-phase trial (Phase I/II) with dose escalation, so safety and effectiveness are not yet proven. Side effects, including severe immune reactions, are possible.

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Study facts

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

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 940 people

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

Started

Feb 2017

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: * Depending upon study part, a history or status of: 1) a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatment regimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant \[ASCT\]) * Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension * Able to provide a tumor tissue pretreatment biopsy at last relapse or during screening from a safely accessible site, per investigator determination, providing the patient has more than one measurable target lesion * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of \>/=12 weeks * AEs from prior anti-cancer therapy must have resolved to Grade less than or equal to (\</=) 1 * Adequate liver, hematological and renal function * Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection * Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) * Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential who are considered to be post-menopausal (at least 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test Exclusion Criteria: * Inability to comply with protocol mandated hospitalizations and restrictions * Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma * Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture * Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing * Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 \[anti-CTLA4\], anti-programmed death 1 \[anti-PD1\] and anti-programmed death ligand 1 \[anti-PDL1\]) within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on Cycle 1 Day -7 * History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents * Documented refractoriness to an obinutuzumab-containing regimen * Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent, including chimeric antigen receptor therapy (CAR-T) within 4 weeks prior to obinutuzumab infusion * Prior solid organ transplantation * Prior allogeneic stem cell transplantation (SCT) * Autologous SCT within 100 days prior to obinutuzumab infusion * Participant with history of confirmed progressive multifocal leukoencephalopathy (PML) * Current or past history of central nervous system (CNS) lymphoma * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a past history of stroke that have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits are allowed * Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases * Participants with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence) * Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina * Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion or anticipation that such a live attenuated vaccine will be required during the study * Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to obinutuzumab infusion. Treatment with corticosteroid \</= 25 mg/day prednisone or equivalent is allowed. Inhaled and topical steroids are permitted * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug * History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus, erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Participants with a remote history of, or well controlled autoimmune disease, may be eligible to enroll after consultation with the Medical Monitor * In Part III diffuse large B-cell lymphoma (DLBCL) dexamethasone cohort, participants with a history of hypersensitivity to dexamethasone or systemic corticosteroids will be excluded

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Conditions

The condition(s) this trial relates to.

B-cell non-Hodgkin lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

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

Non-Hodgkin's lymphoma

Contacts and locations

Locations

AUSL della Romagna

Ravenna, Emilia-Romagna, 48121, Italy
Allegheny Health Network (Pittsburg PA)

Pittsburgh, Pennsylvania, 15212, United States
Auckland Cancer Trial Centre

Auckland, 1023, New Zealand
CHU DE RENNES - CHU Pontchaillou

Rennes, 35033, France
CHU Saint Eloi

Montpellier, 34295, France
Ch Lyon Sud

Pierre-Bénite, 69495, France
China Medical University Hospital

Taichung, 404, Taiwan
Cliniques Universitaires St-Luc

Brussels, 1200, Belgium
Fond. IRCCS Istituto Nazionale Tumori

Milan, Lombardy, 20133, Italy
Helsinki University Central Hospital

Helsinki, 00029, Finland
Hopital Claude Huriez

Lille, 59037, France
Hopital Henri Mondor

Créteil, 94010, France
Hospital Duran i Reynals L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Univ. 12 de Octubre

Madrid, 28041, Spain
Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08915, Spain
Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain
Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain
Hospital del Mar

Barcelona, 08003, Spain
Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy
MSKCC

New York, New York, 10065, United States
Mount Sinai Medical Center

New York, New York, 10029, United States
National Taiwan Universtiy Hospital

Taipei, 100, Taiwan
Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia
Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia
Princess Margaret Cancer Center

Toronto, Ontario, M5G 1Z5, Canada
Rigshospitalet

København Ø, 2100, Denmark
Swedish Cancer Inst.

Seattle, Washington, 98104, United States
UZ Gent

Ghent, 9000, Belgium
University of Michigan

Ann Arbor, Michigan, 48109-0934, United States
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroc?aw, 50-367, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, 60-569, Poland
Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

Prague, 128 08, Czechia
Washington University

St Louis, Missouri, 63110, United States

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