A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
NCT ID: NCT04077723
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
498 participants
INTERVENTIONAL
2019-08-13
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part I
Combination Dose-Escalation: Mixed r/r NHL participants will receive a fixed dose of obinutuzumab up to seven days prior to first administration of englumafusp alfa. Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab in a three-weekly schedule (Q3W).
Englumafusp alfa
Englumafusp alfa will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
Obinutuzumab
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa, then in combination with obinutuzumab Q3W (Part I).
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa or between Day -3 and -7 (Part II and Part III).
Tocilizumab
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Part II
Combination Dose-Escalation: Mixed r/r participants and participants with mixed r/r mantle cell lymphoma (MCL) and Richters transformation will receive a fixed dose of obinutuzumab seven days prior to first administration of englumafusp alfa. Englumafusp alfa will be administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).
Englumafusp alfa
Englumafusp alfa will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
Obinutuzumab
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa, then in combination with obinutuzumab Q3W (Part I).
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa or between Day -3 and -7 (Part II and Part III).
Glofitamab
A fixed dose of glofitamab will be administered Q3W in combination with englumafusp alfa in Part II and Part III
Tocilizumab
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Part III
Dose-Expansion Stage: Participants with r/r diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and DLBCL arising from FL (transformed FL) will receive englumafusp alfa administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).
Englumafusp alfa
Englumafusp alfa will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
Obinutuzumab
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa, then in combination with obinutuzumab Q3W (Part I).
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa or between Day -3 and -7 (Part II and Part III).
Glofitamab
A fixed dose of glofitamab will be administered Q3W in combination with englumafusp alfa in Part II and Part III
Tocilizumab
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Interventions
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Englumafusp alfa
Englumafusp alfa will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
Obinutuzumab
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa, then in combination with obinutuzumab Q3W (Part I).
A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa or between Day -3 and -7 (Part II and Part III).
Glofitamab
A fixed dose of glofitamab will be administered Q3W in combination with englumafusp alfa in Part II and Part III
Tocilizumab
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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City of Hope Medical Center
Pasadena, California, United States
University of California San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver, Colorado, United States
Beth Israel Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
MSKCC
New York, New York, United States
OhioHealth Research Institute
Columbus, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
South Austin Medical Center
Austin, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
UZ Gent
Ghent, , Belgium
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Beijing Cancer Hospital
Beijing, , China
Shandong Cancer Hospital
Jinan, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Aarhus Universitetshospital Skejby
Aarhus N, , Denmark
Rigshospitalet
København Ø, , Denmark
Odense Universitetshospital
Odense C, , Denmark
CHRU de Lille
Lille, , France
CHU Montpellier - Saint ELOI
Montpellier, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU DE RENNES - CHU Pontchaillou
Rennes, , France
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Napoli, Campania, Italy
Asst Papa Giovanni Xxiii
Bergamo, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Auckland City Hospital, Cancer and Blood Research
Auckland, , New Zealand
Waikato Hospital - Cancer and Blood Research Trials Unit
Hamilton, , New Zealand
Pusan National University Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Duran i Reynals L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Univ. 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
The HOPE Clinical Trials Unit
Leicester, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: BP41072 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2019-000416-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502616-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
BP41072
Identifier Type: -
Identifier Source: org_study_id
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