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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
Sponsor: Hoffmann-La Roche
Summary
This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of englumafusp alfa (RO7227166) in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered up to seven days prior to the first administration of englumafusp alfa and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).
Official title: An Open-Label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa (RO7227166, A CD19 Targeted 4-1BB Ligand) in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
498
Start Date
2019-08-13
Completion Date
2027-03-31
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (44)
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
Naples, 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
Clinica Universidad de Navarra Madrid
Madrid, 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