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ACTIVE NOT RECRUITING
NCT04077723
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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).

DRUG

Glofitamab

A fixed dose of glofitamab will be administered Q3W in combination with englumafusp alfa in Part II and Part III

DRUG

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