SC Mosunetuzumab
DrugParticipants will receive SC mosunetuzumab for 12 cycles (cycle length = 21 days or 28 days for Cycle 1 and 28 days for Cycles 2-12)
Other names: RO7030816
NCT Number: NCT05169515
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Soroka, Beersheba, Israel
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Other names: RO7030816
Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
Other names: RO7082859
Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)
Other names: CC-220
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)
Other names: CC-99282
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
Other names: RO5072759
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Other names: RO4877533
Time frame: Until 90 days after the final dose of study treatment
Time frame: Until 90 days after the final dose of study treatment
Time frame: Up to 2 years after start of primary study treatment
Time frame: Until 90 days after the final dose of study treatment
Time frame: Up to 1 year after primary study treatment
Time frame: Up to 2 years after primary study treatment
Time frame: Up to 2 years after primary study treatment
Time frame: Up to 2 years after primary study treatment
Time frame: Up to 2 years after primary study treatment
Time frame: Up to 2 years after primary study treatment
Time frame: Until 90 days after the final dose of study treatment
Time frame: Up to 2 years after primary study treatment
Time frame: Up to 2 years after primary study treatment
Time frame: Up to 12 cycles of study treatment (cycle length = 21 or 28 days for Arm 1 and 21 days for Arm 2)
Time frame: Until 90 days after the final dose of study treatment
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: CO43805 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Hoffmann-La Roche
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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