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An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Summary
This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.
Official title: An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
211
Start Date
2018-05-08
Completion Date
2026-10-16
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Glofitamab
Glofitamab will be administered through IV infusion every 3 weeks (Q3W) beginning Cycle 1, Day 1, for up to 17 cycles (Cycle = 21 days). Step-up dosing, in which an initial lower dose will be followed by a higher dose 1 week later, will be considered for the initial treatment phase and for Cycle 9 of the re-treatment phase.
Atezolizumab
Atezolizumab will be administered in combination with Glofitamab through IV infusion Q3W from Cycle 2, Day 1, for up to 16 cycles (Cycle = 21 days).
Obinutuzumab
Obinutuzumab will be administered once, through IV infusion, at a fixed dose 7 days before the first dose of Glofitamab.
Tocilizumab
Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).
Polatuzumab Vedotin
Polatuzumab vedotin will be administered in combination with Glofitamab (on different days) Q3W from Cycle 1, Day 2, for up to 12 cycles (Cycle = 21 days).
89Zr-Df-IAB22M2C
Participants will receive 89Zr-Df-IAB22M2C (Cycle 1 only) prior to obinutuzumab pre-treatment and again on Day 10 after dosing with glofitamab, followed by PET/CT.
Locations (19)
UZ Gent
Ghent, Belgium
Aarhus Universitetshospital Skejby
Aarhus N, Denmark
Rigshospitalet
København Ø, Denmark
Odense Universitetshospital
Odense C, Denmark
Hadassah Ein Karem Hospital
Jerusalem, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Naples, Campania, Italy
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
Asst Papa Giovanni Xxiii
Bergamo, Lombardy, Italy
Fond. IRCCS Istituto Nazionale Tumori
Milan, Lombardy, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Duran i Reynals
Barcelona, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
The HOPE Clinical Trials Unit
Leicester, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom