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A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
Sponsor: Hoffmann-La Roche
Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC-99282) in participants with B-cell NHL.
Official title: A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
121
Start Date
2022-10-26
Completion Date
2029-09-15
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
SC Mosunetuzumab
Participants will receive SC mosunetuzumab for 12 cycles (cycle length = 21 days or 28 days for Cycle 1 and 28 days for Cycles 2-12)
IV Glofitamab
Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
Iberdomide
Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)
Golcadomide
Arm 1: Participants will receive oral golcadomide from Day 1-14 starting in either Cycle 1 or Cycle 2 through Cycle 12 (cycle length = 28 days for cycles when golcadomide is to be administered) Arm 2: Participants will receive oral golcadomide from Day 1-10 starting in either Cycle 1, Cycle 2 or Cycle 3 through Cycle 12 (cycle length = 21 days)
Obinutuzumab
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Locations (26)
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
Soroka
Beersheba, Israel
Rambam Health Care Campus
Haifa, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
Center Hospital
Ramat Gan, Israel
Sourasky Medical Center
Tel Aviv, Israel
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, Italy
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia
Pisa, Piedmont, Italy
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Spain
Clinica Universidad de Navarra-Madrid
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hosp Universitario Salamanca
Salamanca, Spain
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
University College London Hospitals
London, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, United Kingdom