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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
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)
Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)
Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]
Time frame: Until 90 days after the final dose of study treatment
Percentage of participants with adverse events [all cohorts]
Time frame: Until 90 days after the final dose of study treatment
Best overall response rate (ORR), defined as the proportion of participants whose best overall response is a partial response (PR) or a complete response (CR) during the study, as determined by the investigator using Lugano 2014 criteria [dose expansion]
Time frame: Up to 2 years after start of primary study treatment
Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose escalation]
Time frame: Until 90 days after the final dose of study treatment
Best CR rate, defined as the proportion of participants whose best overall response is a CR during the study, as determined by the investigator using Lugano 2014 criteria [all cohorts]
Time frame: Up to 1 year after primary study treatment
Best ORR (CR or PR at any time) on study as determined by the investigator using Lugano 2014 criteria [dose escalation]
Time frame: Up to 2 years after primary study treatment
Duration of response (DOR) as determined by the investigator using Lugano 2014 criteria [all cohorts]
Time frame: Up to 2 years after primary study treatment
Progression-free survival (PFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Reference Study ID Number: CO43805 https://forpatients.roche.com/
CONTACT
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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)
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
San Francisco, California, United States
RECRUITINGUniversity of Colorado
Aurora, Colorado, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGThe University of Chicago
Chicago, Illinois, United States
RECRUITINGLevine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGUT MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSoroka
Beersheba, Israel
RECRUITINGRambam Health Care Campus
Haifa, Israel
RECRUITINGHadassah University Hospital - Ein Kerem
Jerusalem, Israel
RECRUITINGCenter Hospital
Ramat Gan, Israel
RECRUITING...and 16 more locations
Time frame: Up to 2 years after primary study treatment
Event-free survival (EFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Time frame: Up to 2 years after primary study treatment
Overall survival (OS) [dose expansion]
Time frame: Up to 2 years after primary study treatment
Percentage of participants with adverse events [dose expansion]
Time frame: Until 90 days after the final dose of study treatment
Serum concentration of subcutaneous (SC) mosunetuzumab [all cohorts]
Time frame: Up to 2 years after primary study treatment
Serum concentration of intravenous (IV) glofitamab [all cohorts]
Time frame: Up to 2 years after primary study treatment
Serum concentration of CC-220 and CC-99282 (CELMoDs) [all cohorts]
Time frame: Up to 12 cycles of study treatment (cycle length = 21 or 28 days for Arm 1 and 21 days for Arm 2)
Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose expansion]
Time frame: Until 90 days after the final dose of study treatment