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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

498

Participants

Timeline

Start Date

August 13, 2019

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Lymphoma, Non-Hodgkin
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).

Trial Locations (39)

1023

RECRUITING

Auckland City Hospital, Cancer and Blood Research, Auckland

2100

RECRUITING

Rigshospitalet, København Ø

3000

RECRUITING

Peter Maccallum Cancer Centre, Melbourne

3004

RECRUITING

The Alfred Hospital, Melbourne

3204

RECRUITING

Waikato Hospital - Cancer and Blood Research Trials Unit, Hamilton

5000

RECRUITING

Odense Universitetshospital, Odense C

8200

RECRUITING

Aarhus Universitetshospital Skejby, Aarhus N

9000

RECRUITING

UZ Gent, Ghent

20089

RECRUITING

Istituto Clinico Humanitas, Rozzano

20141

RECRUITING

Irccs Istituto Europeo Di Oncologia (IEO), Milan

24127

RECRUITING

Asst Papa Giovanni Xxiii, Bergamo

28041

RECRUITING

Hospital Univ. 12 de Octubre, Madrid

29010

RECRUITING

Hospital Clinico Universitario Virgen de la Victoria, Málaga

34295

RECRUITING

CHU Montpellier - Saint ELOI, Montpellier

35033

RECRUITING

CHU DE RENNES - CHU Pontchaillou, Rennes

49241

RECRUITING

Pusan National University Hospital, Busan

59037

RECRUITING

CHRU de Lille, Lille

63110

RECRUITING

Washington University School of Medicine, St Louis

69495

RECRUITING

Centre Hospitalier Lyon Sud, Pierre-Bénite

80131

RECRUITING

Istituto Nazionale Tumori Irccs Fondazione g. Pascale, Napoli

80218

RECRUITING

Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center, Denver

91105

ACTIVE_NOT_RECRUITING

City of Hope Medical Center, Pasadena

94158

RECRUITING

University of California San Francisco, San Francisco

100142

RECRUITING

Beijing Cancer Hospital, Beijing

201315

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

250117

RECRUITING

Shandong Cancer Hospital, Jinan

361003

RECRUITING

The First Affiliated Hospital of Xiamen University, Xiamen

02215

RECRUITING

Beth Israel Medical Center, Boston

43221-2417

RECRUITING

OhioHealth Research Institute, Columbus

77030-4009

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

B3H 2Y9

RECRUITING

Queen Elizabeth II Health Sciences Centre, Halifax

H3T 1E2

RECRUITING

Jewish General Hospital, Montreal

03080

RECRUITING

Seoul National University Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08908

RECRUITING

Hospital Duran i Reynals L'Hospitalet, L'Hospitalet de Llobregat

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

LE1 5WW

RECRUITING

The HOPE Clinical Trials Unit, Leicester

W1T 7HA

RECRUITING

University College London Hospitals NHS Foundation Trust, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY