New drug cocktail aims to tackle tough lymphoma

NCT ID NCT04077723

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

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests a new drug called englumafusp alfa, which helps the immune system attack cancer cells. It is given together with either obinutuzumab or glofitamab to people whose B-cell non-Hodgkin lymphoma has returned or stopped responding to treatment. The trial has three parts and will check safety, side effects, and whether the combination shrinks tumors. About 498 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: englumafusp alfa (a targeted protein that boosts immune cells) combined with obinutuzumab or glofitamab (antibody drugs)
What this could lead to: If successful, this could offer a new treatment option for people with hard-to-treat B-cell non-Hodgkin lymphoma that has not responded to prior therapies.
What could go wrong: This is an early-phase trial (phase I/II) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects from immune activation are possible.

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 1/2

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

Participants

About 498 people

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

Started

Aug 2019

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: * History or status of a histologically-confirmed hematological malignancy that is expected to express CD19 and CD20; relapse after or failure to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival (Part I and II); relapsed after or failed to respond to only one prior systemic treatment regimen (Part III) * Must have at least one measurable target lesion (\>/= 1.5 cm) in its largest dimension by computed tomography scan * Able and willing to provide a fresh biopsy from a safely accessible site, per Investigator's determination, providing the participant has more than one measurable target lesion * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or \</= 2 for some participants in Part III * Life expectancy of \>/= 12 weeks * Adverse events from prior anti-cancer therapy must have resolved to Grade \</= 1 * Adequate liver, hematological, and renal function * Negative test results for acute or chronic hepatitis B virus infection * Negative test results for hepatitis C virus and HIV * The contraception and abstinence requirements are intended to prevent exposure of an embryo to the study treatment. The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of preventing drug exposure * Female participants: A female participant is eligible to participate if she is not pregnant and not breastfeeding, and if at least one of the following applies: women of non-childbearing potential (WONCBP); women of child bearing potential (WOCBP) who agree to remain abstinent or use two highly effective contraceptive methods with a failure rate of \<1% per year during the treatment period and for at least 18 months after obinutuzumab or 3.5 months after the last dose of englumafusp alfa, 2 months after last dose of glofitamab, or 3 months after the last dose of tocilizumab, whichever is longer. Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal occlusion/ ligation, male sexual partner who is sterilized, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method; have a negative pregnancy test (blood) within the 7 days prior to the first study treatment administration * Male participants: During the treatment period and for at least 3 months after obinutuzumab, or 3.5 months after the last dose of englumafusp alfa, 2 months after the last dose of glofitamab, or 2 months after the last dose of tocilizumab whichever is longer, agreement to: Remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year, with a partner who is a women of childbearing potential. With pregnant female partner, remain abstinent or use contraceptive measures such as a condom to avoid exposing the embryo; refrain from donating sperm during this same period Exclusion Criteria: * Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count (ALC) or the presence of abnormal cells in the peripheral blood signifying circulating lymphoma cells (for some participants in Part III, ALC only) * 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 (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics * Pregnant or breast-feeding or intending to become pregnant during the study * Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines or monoclonal antibodies within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion * History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents and auto-immune disease * Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational or approved anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to obinutuzumab infusion * Prior solid organ transplantation * Prior allogeneic stem cell transplant * Autologous stem cell transplant within 100 days prior to obinutuzumab infusion * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy and confirmed progressive multifocal leukoencephalopathy * Current or past history of central nervous system (CNS) lymphoma and CNS disease * 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 * Major surgery or significant traumatic injury \< 28 days prior to the Gpt infusion or anticipation of the need for major surgery during study treatment * Participants with another invasive malignancy in the last 2 years * Significant cardiovascular disease * Administration of a live, attenuated vaccine within 4 weeks before Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study * Received systemic immunosuppressive medications (including but not limited to cyclohosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to Gpt, with the exception of corticosteroid treatment \<=25 mg/day of prednisone or equivalent, however there must be documentation that the participant was on a stable dose of at least a 2-week duration prior to Gpt infusion. Inhaled and topical steroids are permitted

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Conditions

The condition(s) this trial relates to.

B-cell non-Hodgkin lymphoma lymphoma, non-Hodgkin, familial non-Hodgkin lymphoma

As listed by the trial registrant

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

Lymphoma, non-Hodgkin

Contacts and locations

Locations

Aarhus Universitetshospital Skejby

Aarhus N, 8200, Denmark
Asan Medical Center

Seoul, 05505, South Korea
Asst Papa Giovanni Xxiii

Bergamo, Lombardy, 24127, Italy
Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand
Beijing Cancer Hospital

Beijing, 100142, China
CHRU de Lille

Lille, 59037, France
CHU DE RENNES - CHU Pontchaillou

Rennes, 35033, France
CHU Montpellier - Saint ELOI

Montpellier, 34295, France
Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France
City of Hope Medical Center

Pasadena, California, 91105, United States
Fudan University Shanghai Cancer Center

Shanghai, 201315, China
Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain
Hospital Univ. 12 de Octubre

Madrid, 28041, Spain
Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain
Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, 20141, Italy
Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale

Naples, Campania, 80131, Italy
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
Odense Universitetshospital

Odense C, 5000, Denmark
Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia
Pusan National University Hospital

Busan, 49241, South Korea
Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada
Rigshospitalet

København Ø, 2100, Denmark
Samsung Medical Center

Seoul, 06351, South Korea
Seoul National University Hospital

Seoul, 03080, South Korea
Shandong Cancer Hospital

Jinan, 250117, China
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
The First Affiliated Hospital of Xiamen University

Xiamen, 361003, China
The HOPE Clinical Trials Unit

Leicester, LE1 5WW, United Kingdom
The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States
UZ Gent

Ghent, 9000, Belgium
University College London Hospitals NHS Foundation Trust

London, W1T 7HA, United Kingdom
University of California San Francisco

San Francisco, California, 94158, United States
Waikato Hospital - Cancer and Blood Research Trials Unit

Hamilton, 3204, New Zealand
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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